Probiotic for ulcerative colitis

PMC

DISCUSSION

The mean count of lactobacilli in some studies was similar to our study, with 8 log CFU/mL, 7.2 log CFU/mL, and 1.2×107 CFU/mL of lactobacilli, respectively, in kefir (14,15,16). A 5×107 CFU/mL count of LAB colony forming units was found in a kefir sample as the total average count in our study.

We isolated L. kefiri from kefir. Pintado et al. isolated L. kefiri from Portuguese kefir by using API 50 as the same. Chen et al. also identified L. kefiri from the kefir in Taiwan (22,23).

Our data indicated that the selected LK 9 L. kefiri strains were colonized in the gut of this study of patients. As similarly seen in the study by Toscano et al., after 1 month of L. kefiri LKF01 administration, the Lactobacillus strain was detected in the feces of all subjects participating in our study with a bacterial load of 105–106 CFU/g. According to the same study, L. kefiri showed a strong ability to modulate the gut microbiota composition, leading to a significant reduction of several bacterial genera directly involved in the onset of proinflammatory response and GI diseases (24).

According to Braat et al., there was a decrease in the number of CRP levels of patients with CD consuming L. lactis for 1 week (25). In our study, CRP levels decreased after a 28-day kefir consumption of patients with CD, and it was statistically significant (p=0.015). The number of studies evaluating the immunomodulatory properties of probiotics is increasing. The immunomodulatory properties of kefir may be due to the direct action of the microbicide or may be indirect through different bioactive compounds produced during the fermentation process (25). The immunomodulatory effect of kefir may be attributed to its ability to reduce or repair intestinal permeability of these probiotics. Thus, contact between the antigens in the host and intestinal lumen is reduced, which can reduce the inflammatory response (26). IBD is associated with the intestinal microflora. In humans with IBD, there are a low number of lactobacilli and bifidobacteria and a large number of anaerobic bacteria. Treatment is performed using probiotics to help the patient maintain the remission period (27). In the intestines of individuals with IBD, the numbers of Lactobacillus and Bifidobacterium are lower, and anaerobes are higher. Probiotics do not cure the disease; however, after some time, they may prolong the remission period. This increases the quality of life of patients (25). According to data from our study, a statistically significant difference was observed in abdominal pain score (p=0.049) and feeling good score (p=0.019) for patients who consumed kefir, which contains probiotics. They have positive effects on diseases caused by an imbalance of the intestinal microflora (28).

Some studies show that probiotics have effects on patients with UC and CD (29). According to Tursi et al. (2010), VSL # 3 probiotic mixture reinforcement is safe and can reduce the UC Disease Activity Index (UCDAI) scores in patients affected by mild to moderate UC treated with 5-aminosalicylic acid and/or immunosuppressants. In addition, it improves rectal bleeding and regenerates remission in patients with recurrent UC after 8 weeks of treatment. However, these parameters do not reach statistical significance (30).

The study was performed in a small open-label study in patients with active UC. Compared with 10 patients treated with inactivated bacteria given live L. plantarum 299v, 6 out of 9 patients reached remission (31).

Patients with relapses with mild to moderate UC were treated with 3×250 mg/day probiotic Saccharomyces boulardii for 4 weeks. A 68% remission rate was observed (32).

Patients with UC who were on remission in a placebo-controlled study using fermented pills containing 1×1010 CFU Bifidobacterium breve, Bifidobacterium bifidum, and L. acidophilus were given 100 mL milk for 12 months. At the end of the study period, 73% of patients in the fermented milk group remained in remission, whereas the number was 10% for the placebo group, and a significant difference was detected in clinical remission; however, no difference was found 1 year after colonoscopy (33).

One of the other studies was the one which forty patients with clinical and endoscopic remissions participated in the randomized, placebo-controlled trial. VSL # 3 was infected with 6 g/day for 9 months. Fecal samples showed significantly increased fecal concentration of Lactobacillus, bifidobacteria, and Streptococcus thermophilus after pretreatment and treatment (p<0.01) only in baseline levels in the VSL # 3 treated group (34).

We also found that the amount of Lactobacillus in patients’ feces at the end of 1 month of kefir consumption was between 104 and 109 CFU/g for all subjects. For L. kefiri, it was found to be between 104 and 106 CFU/g in 17 patients, and the change in the amount of Lactobacillus was significant.

In one study related to lactose intolerance, a group of subjects were fed low-fat milk, and another group was fed with kefir. The subjects have lactose intolerance. Lactose intolerance is caused by low β-galactosidase (lactase) activity in the intestine. Diarrhea and pain in the abdomen were observed in the milk group, but these effects were not observed in the kefir group (35). In lactose intolerance, individuals have an osmotic effect by lactose fermentation, which is not digested due to enzyme deficiency, and lactose and methane, hydrogen, and organic acids emerge, which cause discomfort. Dairy products can cause gas and bloating in patients with CD and UC. Nevertheless, since kefir has Lactobacillus that degrades lactose in the intestines, no one complained about lactose intolerance symptoms, such as abdominal pain and gas, in our study (36). Patients with CD and UC who cannot consume dairy products can easily consume kefir, and they do not feel uncomfortable and cannot stay away from calcium source.

In an experiment on 10 patients with IBD, VSL # 3 probiotic mixture was administered to the patients for 2 months, and the stool was analyzed by PCR. As a result, colonization of S. thermophilus, Bifidobacterium infantis Y1, and B. breve Y8 strains was found to be similar to healthy individuals (37).

One study was conducted to directly detect S. thermophilus in human feces, except culture-based techniques or DNA isolation and purification procedures with culture-independent PCR protocol. The persistence of S. thermophilus in the intestines of 10 healthy subjects who were given VSL # 3 or yogurt was investigated. The bacteria sought after 3 days of administration were detected and continued to be found 6 days after treatment suspension.

Manichanh et al. (38) found a significant decrease in the Clostridium family in patients with CD using the DNA microarray-based analysis method, but no significant variation was found in the Bacteroides family.

A 16S rDNA-column library index method was used in the study by Gophna et al. (39) for the analysis of IBD intestinal microbiota. In conclusion, a decrease in the number of Bacteroidetes and Proteobacteria in CD, but a decrease in the Clostridium family, was observed.

The general composition of the intestine is considered most relevant in the etiology and pathogenesis of IBD. However, microbiota analyses are long and labor intensive, and as a result, only cultivable bacterium can detect 20%–30% of microbiota. Owing to complex anaerobic environment requirements, the rest cannot be cultured. Therefore, molecular approaches are widely used for microbiota analysis (40).

In a study investigating whether the fecal microbiome of patients with UC and CD differed from healthy individuals, studies using terminal restriction fragment length polymorphism analysis showed differences. However, the intestinal microbiology of patients with inactive UC is similar to that of healthy individuals. Identification of the intestinal mechanisms of these patients and changes in microbiota structure may contribute to the development of new treatment options for patients with UC and CD (40).

When constantly consumed, the lactobacilli in the kefir settle in the intestines and produce acid components that correct the microflora against the pathogenic bacteria, thus the diseased bacteria can be removed (41).

Although pathogenic bacteria, such as Salmonella and Shigella, have been associated with the presence of kefir starter, these pathogens have not been developed (42). In addition, LAB and yeast present in the microflora have an inhibitory effect on kefir intestinal microorganisms (43). Kefir reduces the time of transit time by allowing feces to be easily thrown away. When antibiotic therapy is applied, it improves the irregular bowel flora (41).

Patients with UC and CD who started to use kefir in our study were seen to have been colonized by kefir probiotics according to the first week and the last 2 weeks when they started to establish a positive balance in the gut. Since the results in the literature are mostly obtained by different symptom evaluation methods, we are unable to make a direct comparison with data from our study.

In our study, the decrease in abdominal pain and bloating scores in the IBD group compared with the control group was similar to Nagendra and Shah (44).

The effect of S. boulardii was also investigated in a study on the effect of CD. Patients who were in remission from CD have been treated with idiopathic remedies. In this treatment, mesalamine was administered to a group of 3×g/day. The other group was S. boulardii for 1 month and 2×1 g/day mesalamine for 6 months. The remission rate in the group administered only mesalamine was 38%. The remission rate for mesalamine and S. boulardii was 94% (32).

In patients with CD, there are experiments with Lactobacillus salivarius UCC118 and Lactobacillus GG as probiotics. The results obtained for these patients are not sufficient, nonetheless promise future work.

In a meta-analysis, probiotics, which failed to prevent remission in CD and prevent clinical and endoscopic recurrence, have been recommended to use probiotic preparations containing a mixture of Lactobacillus, Escherichia coli, or Saccharomyces (45).

A pilot study by Gupta et al. showed that Lactobacillus GG can increase the intestinal barrier function in children with mild to moderate active CD (46).

In a double-blind, randomized, controlled study with Lactobacillus GG, children with CD did not prolong their recurrence time (47).

Saccharomyces boulardii with mesalazine has been found to be effective only in the recurrence control group when administered mesalazine (32).

In the study conducted by Steed et al. in 2010, by reviewing patients with active CD, they were given a symbiotic containing Bifidobacterium longum and as a result found to be effective when compared with the placebo. In the treatment of CD, randomized, controlled trials have proven the effectiveness of probiotics (48).

In our study of the microbial analysis of feces, the kefir treatment group showed significantly higher fecal lactobacilli count than the control group. This has been attributed to their ability to survive at low pH and high bile concentration as in in vitro experiments. These potentially probiotic bacteria colonizing the intestinal mucosa provide a barrier to pathogens through various mechanisms, competition for nutrients, and the production of antimicrobials.

According to Toscane et al. (24), L. kefiri appears to be effective and safe to maintain remission in patients with UC and may be a good treatment option for preventing relapse in this group of patients. L. kefiri LKF01 demonstrated a strong ability in modulating the intestinal microbiota composition, leading to a significant decrease in several bacterial generations at the onset of direct proinflammatory response and GI disorders.

Although the etiology of CD is uncertain, evidence suggests the involvement of intestinal bacteria, and studies have shown that bacterial, fusobacteria, enterococci, E. coli, and fewer bifidobacteria, lactobacilli, eubacteria, Clostridium coccoides, and Clostridium leptum showed higher concentrations in patients with CD. In Faecalibacterium prausnitzii and remission from healthy individuals, populations of fecal bacteria changed (48).

Probiotics can effectively protect UC remission, but little is known about their ability to induce remission. Adult patients with mild to moderate UC were randomized to receive 3.6×1012 CFU VSL # 3 (n=77) twice daily for 12 weeks and placebo (n=70). In the UCDAI, a reduction of 50% was achieved at 6 weeks. UCDAI is a measure of the degree of fecal incidence, rectal bleeding, mucosal appearance, and disease activity of the physician. The percentage of patients with a >50% improvement in the UCDAI score at week 6 was compared with the placebo-treated group (10%; 0.001) in the VSL # 3 given group (25% vs. 32.5%). At week 12, 33 (42.9%) patients receiving VSL # 3 entering remission were compared with 11 (15.7%) placebo patients (p<0.001). In addition, it was observed that the number of patients given VSL # 3 (40%; 51.9%) decreased by 3 points in UCDAI compared with placebo (13%; 18.6%) (p<0.001). The VSL # 3 group showed significantly greater reductions in UCDAI scores and symptoms at 6 and 12 weeks compared with the placebo group (49).

Other studies have confirmed that probiotic bacteria may increase the integrity of tight junctions between intestinal epithelial cells during infections or inflammatory conditions. For this reason, colonization with probiotic bacteria may cause exposure of immune cells to bacterial antigens believed to induce IBD. Experimental colitis showed that the protective effects of probiotic microorganisms (VSL # 3) in a dextran sulfate sodium model were mediated by DNA as recognized by the mucosal Toll-like receptor 9 receptor. This interaction subsequently led to increased endogenous production of bacterial survival beta-defensin and antibacterial peptides. In addition, it has been reported that treatment of VSL # 3 cultured intestinal epithelial cells leads to an increase in transepithelial electrical resistance, a change associated with reduced permeability. In the present study, incubation of intestinal epithelial cells with this probiotic consortium also induced the expression of various mucins, resulting in decreased adhesion of microorganisms and components to the epithelial surface (50). According to our study, probiotics have been evaluated in animal models and in some clinical trials. Oral administration of probiotics with VSL # 3 has been shown to normalize the interleukin 10 barrier function in IBD mice. VSL # 3 is a probiotic cocktail consisting of eight different Gram-positive organisms. Many studies on kefir’s biological activities have revealed that kefir has anti-inflammatory, immunomodulatory, and antimicrobial activities and is a functional food (51). Regular kefir consumption is associated with lactose intolerance and tolerance; antibacterial effect; hypocholesterolemic effect; control of plasma glucose; antihypertensive and anti-inflammatory effects; antioxidant, anticarcinogenic, and anti-allergic activities; and healing effects. Much of the work supporting these findings has been made in vitro or in animal models (52). All studies show that probiotics may play an important role in the management of IBD in the future, despite the fact that current clinical trials do not have statistical power, probably due to limited data. The availability of new techniques to better understand bacterial and host interactions and to better define the microbiota modification in different clinical subclasses may be a key to the success of effective probiotic therapy in patients with IBD (50).

Study disadvantages and limitations

Our study has some limitations. Moreover, the literature on IBD data is insufficient to reach at definite conclusions about the changes in the quality of life. Short-term kefir consumption and changes in the quality of life in our study may not have been revealed by patients. Inadequate number of patients may prevent the statistical significance of the changes.

The small sample size and short time are major weak points of the present study; however, it is very difficult for patients who have UC and CD to consume anything due to their illness. They especially want to know the effect of the symptoms of the diseases before consuming a different food. The lack of study on kefir was also questioned by the patients. One other limitation of our study was that the questionnaires were self-administered by the patients.

One advantage of our study was that we performed both feces analysis and concurrent assessment of bloating, defecation consistency, defecation, and feeling good scores with biochemical parameters at the same time. We also measured the severity of symptoms.

According to data from our study, regular kefir usage may improve both symptoms and quality of life in the short term in patients with IBD. The actual effects of probiotics on intestinal ecology are still to be discussed, as differences in microbial strains have a number of factors to be explored, such as their concentration and formulations.

Kefir has a tart, creamy flavor and apart from having a high nutritional value, it is also known to have a probiotic effect (53). Probiotic bacteria should be produced as an alternative to industrial probiotics through non-transgenic microorganisms isolated from natural food products such as kefir (54).

There are many useful probiotic microorganisms in kefir. It is easy to find and is inexpensive. We investigated the undefined effects of kefir in patients with IBD, Lactobacillus and L. kefiri flora of feces, and biochemical parameters and disease symptoms. Further studies are needed to evaluate the best dose-response effect of kefir, including monitoring patients to assess the persistence of potential beneficial effects in patients with CD and UC following kefir intervention. Unfortunately, countless human research conducted with kefir is often poorly designed. More human studies should be conducted to demonstrate the effect of kefir consumption and reduce the risk of disease. In addition, the actual effects of probiotics affecting intestinal ecology should be investigated, and advanced studies should be conducted on disease-specific food product formulations with customized studies on microbial strains in well-designed randomized clinical trials. The trials should continue on greater patient populations.

The Pros and Cons of Probiotics for Ulcerative Colitis

Natural food sources of probiotic bacteria are probably safe if you have UC. Getty Images

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Scan the shelves and the refrigerated section of your local supermarket or pharmacy and you’re likely to spot pills, powders, supplements, and foods with probiotics — from yogurt and buttermilk to miso and sauerkraut. Probiotics are live “friendly” bacteria that commonly inhabit the large intestine (colon) as part of its microflora and aid in digestion and normal functioning. They’re also grown in labs and added to foods or sold as dietary supplements — packing in about 10 to 20 billion colony-forming units (CFUs) per capsule, according to a 2008 paper in the journal American Family Physician.

It’s important to note that not all probiotics are alike. There are many strains, so one may not have the same effect as another. They can vary widely in their CFUs and overall quality, and researchers aren’t yet sure which probiotics are helpful and which are not — for ulcerative colitis (UC) or for other health conditions. However, according to a promising review published in June 2017 in Alimentary Pharmacology and Therapeutics, probiotic foods or supplements containing a probiotic called VSL #3 may help people manage UC.

“Patients with UC have an imbalance in their gut bacteria,” says David Hudesman, MD, the medical director of the inflammatory bowel disease center at New York University’s Langone Health in New York City. And yet, “we don’t have a great understanding of how to apply that clinically,” he says. In other words, more studies on probiotics and UC need to be done to assess which types of probiotics may help and how.

Probiotics may still have a place in your treatment plan as long as you know what they can do for you.

How Probiotics Can Help With Ulcerative Colitis

Treating UC requires a two-pronged approach: managing the symptoms you feel and managing the inflammation in your colon to put the disease into clinical remission. “Feeling well and being healed inside don’t always go together,” Dr. Hudesman says. “Until we know more, don’t expect that using a probiotic will fix the underlying inflammation.”

But if you have noticeable symptoms such as gas, bloating, and loose bowel movements, using probiotics might help you find some relief. Ways to incorporate probiotics into your diet include:

  • Eating yogurt that advertises live, active cultures on the label
  • Drinking kefir, a fermented milk drink
  • Eating kimchi, a Korean side dish of salted and fermented vegetables

If you’re interested in taking a probiotic supplement, talk to your doctor first. Whether in food or supplement form, probiotics should only be used to complement other treatments for UC. So if your doctor prescribed medication for your UC, don’t stop taking it.

“Use probiotics with your usual medical therapy, if needed,” Hudesman says.

There’s stronger evidence, published in 2014 in the journal Current Pharmaceutical Design, for using probiotics, specifically VSL #3, to prevent pouchitis in those who no longer have a colon. Pouchitis occurs when the lining of the pouch becomes inflamed after ulcerative colitis surgery. Hudesman says he routinely recommends VSL #3 for patients who have had more than one bout of pouchitis. VSL #3 contains eight different probiotic strains and is available in three different potencies. If you’ve had pouchitis, ask your doctor about VSL #3 and whether it’s worth a try, plus which potency might work for you.

The Downside of Probiotics for Ulcerative Colitis

Depending on your personal gut microbiome, which contains 10 to 100 trillion bacteria, probiotics could make symptoms worse. “Certain probiotics for certain people can also lead to more gas, more bloating, and looser stools,” Hudesman says. “We see that a lot.”

“We know the intestinal flora is very important to the development of IBD,” says Jessica Philpott, MD, PhD, a gastroenterologist who specializes in IBD at the Cleveland Clinic in Ohio. “But more research is needed to have a better understanding of how to adjust the intestinal flora — either with probiotic supplements, medications, or foods — to treat or even prevent IBD.”

Probiotics could even make your UC worse. “If you’re very sick with severe colitis and use probiotics rather than known, effective therapies, you might incur some harm in delaying to treat the colitis,” Dr. Philpott says.

Another downside: Probiotics are sold as dietary supplements, which are not regulated by the Food and Drug Administration (FDA). In fact, the FDA has not approved probiotics to prevent or treat any health condition as of yet. “There are numerous probiotic therapies with many different types of bacteria, numbers, and delivery agents,” Philpott says. “One probiotic may provide health benefits in a certain environment, while another probiotic strain may not.”

Perhaps in the near future, when (and if) probiotics are deemed ready for prime-time clinical use, doctors may be able to check your stool and prescribe the right probiotic or diet for you. Until then, don’t take using a probiotic lightly.

“When I talk with UC patients about probiotics, nutrition, and diet, I have them see a nutritionist who specializes in IBD as needed,” Hudesman says.

Philpott agrees. “Before taking a probiotic, I recommend talking with your healthcare provider to evaluate the pros and cons and make an informed decision.” You should also talk to your doctor about which type of probiotic you want to take — just in case it triggers any side effects.

Probiotics and Ulcerative Colitis: Effectiveness and Treatment

Did you know that the inside walls of your intestines are covered with bacteria?

Most of the time, these intestinal bacteria don’t cause problems. In fact, some of the bacteria help your body digest food as well as prevent other, less helpful bacteria from thriving in your intestine.

Helping this “microbiome” in your intestines flourish is the basic purpose of probiotics, or so-called “good bacteria.”

What are probiotics?

Probiotics are microorganisms that we take into our bodies to support our health. Typically, they’re strains of bacteria that can help improve our digestion. Probiotic products are intended to supply healthy, gut-friendly bacteria to populate the intestinal wall.

Probiotics are found in certain foods. They also come in supplements, which are available in a variety of forms, including tablets and capsules.

While many people take probiotics to support their general digestive health, they’ve also been used to treat certain intestinal problems such as gastroenteritis and a condition called pouchitis. But can these good bacteria also be used to treat ulcerative colitis?

Probiotic treatment options for ulcerative colitis

Ulcerative colitis (UC) is an inflammatory disease of the large intestine that causes bloody diarrhea, cramping, and bloating. The disease is relapsing and remitting, which means there are times when the disease is quiet, and other times when it flares up, causing symptoms.

Standard medical treatment for UC has two components: treating active flare-ups and preventing flare-ups. With traditional treatment, active flare-ups are often treated with corticosteroids such as prednisone. Flare-ups are prevented with maintenance treatment, which means using certain drugs long term.

Let’s look at whether probiotics can help with either of these treatment needs.

Can probiotics help stop flare-ups?

The answer to this question is likely no. A 2007 review of clinical studies on the use of probiotics for UC flare-ups found that probiotics do not shorten the duration of a flare-up when added to regular treatment.

However, the people in the studies taking probiotics reported fewer symptoms during the flare-up, and these symptoms were less severe. In other words, while probiotics did not end the flare-up faster, they seemed to make the symptoms of the flare-up less frequent and less severe.

Can probiotics help prevent flare-ups?

The use of probiotics for this purpose shows more promise.

Several studies have shown that probiotics may be as effective as traditional UC medications, including the gold-standard treatment mesalazine.

A 2004 German study followed a group of 327 patients with a history of UC, giving half of them mesalazine and the other half probiotics (Escherichia coli Nissle 1917). After one year of treatment, the average time to remission (time without a flare-up) and the quality of remission was the same for both groups.

Similar results have been seen in other studies. And another probiotic, Lactobacillus GG, may also be helpful in sustaining remission in UC.

How do probiotics help treat ulcerative colitis?

Probiotics may help in treating UC because they address the actual cause of the condition.

UC is thought to be caused by problems with the immune system in the intestines. Your immune system helps your body fight disease, but it can sometimes lash out and target your own body in an effort to protect it from a perceived danger. When this happens, it’s called an autoimmune disease.

In the case of UC, an imbalance of bacteria in the large intestine is thought to be the perceived danger that prompts the immune system to respond.

Probiotics may help resolve this problem by providing good bacteria that help restore the bacterial balance in the intestine, eliminating the problem that the immune system is responding to. With the perceived danger gone, the immune system may soften or stop its attack.

Pros and cons of using probiotics for ulcerative colitis

There seem to be more pros than cons in the use of probiotics for UC.

Pros

So far, no serious side effects have been linked with prolonged use of probiotics for UC. In a review of studies, the rate of side effects was about the same (26 percent vs. 24 percent) in probiotics users as in those taking mesalazine.

As we stated previously, probiotics may help increase the time between flare-ups and may make the symptoms of a flare-up less severe. Also, probiotics are likely less expensive than typical UC medications, and they may be safer over long periods.

Probiotics may also protect against other bowel problems such as Clostridium difficile colitis and travelers’ diarrhea.

Cons

That’s a lot of benefits, but there are a few cons of using probiotics with UC. The main one is that they’re probably not useful in causing a faster remission during a flare-up of UC.

Another con is that certain people should use them cautiously. Probiotics contain living bacteria, so they may increase infection risk in people with compromised immune systems (such as those taking long-term or high-dose corticosteroids). This is because a weakened immune system might not be able to keep the live bacteria in check, and an infection may result.

Pros of probiotics for UC

  • May help prevent UC flare-ups
  • May reduce symptoms during flare-ups
  • No serious side effects shown to date
  • Less expensive than other UC medications
  • Possibly safer for long-term use than other UC medications
  • May protect against other bowel diseases, such as C. difficile infection

Cons of probiotics for UC

  • Don’t stop flare-ups in process
  • Should be used with caution in people with weakened immune systems

Where can I get probiotics?

There are countless types of probiotic products available and many strains of microorganisms that may be used in them. Two of the most common types of bacteria used are Lactobacillus and Bifidobacterium.

You can get probiotics from a range of sources. You can find them in foods such as yogurt, kefir (a fermented drink made from cow’s milk), and even sauerkraut. You can also take them as supplements, in forms such as capsules, tablets, liquids, or gummies. Your local pharmacy likely has several options available.

If you’re thinking of using probiotics, you should keep in mind that unlike prescription drugs, probiotic supplements are not regulated by the U.S. Food and Drug Administration (FDA). The FDA doesn’t check whether supplements are safe or effective before they go on the market.

If you would like guidance on finding a high-quality probiotic, talk to your doctor.

Talk to your doctor

Even though probiotics are easy to get and have few side effects, you should talk to your doctor before adding them to your UC treatment plan. This is especially important if you have a compromised immune system or are on high-dose corticosteroids.

And definitely don’t use probiotics to replace any UC medications or treatment your doctor has advised without confirming with your doctor first.

But if you and your doctor think probiotics are the next option to consider for your UC treatment plan, ask your doctor for help in finding the best probiotic for you. You’ve likely got nothing to lose — except possibly some UC flare-ups.

PRObiotic VSL#3® for Maintenance of Clinical and Endoscopic REMission in Ulcerative Colitis (PROREM UC)

Inclusion Criteria:

  1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
  2. Subjects are willing and able to participate in the study, complete subject assessments, attend scheduled clinic visits, and comply with all protocol requirements as evidenced by written informed consent.
  3. Male and/or female subjects aged ≥18 years at the time of informed consent.
  4. A diagnosis of UC for ≥3 months. A biopsy report must be available to confirm the histological diagnosis in the subject’s source documentation. In addition, a report documenting disease duration and extent of disease (e.g., proctosigmoiditis, left-sided colitis and pancolitis) based upon prior colonoscopy must also be available in source documentation.
  5. Must have a flexible sigmoidoscopy indicative of UC in remission (Mayo endoscopic subscore ≤1) during screening period, to be performed after all other inclusion criteria have been met.
  6. Must have history of previous mild-to-moderate active disease beyond the rectum (>15 cm from the anal verge).
  7. Must have UC in remission with a Total Mayo Score ≤2 with no individual subscore>1 and rectal bleed subscore of 0.
  8. Must be on maintenance treatment with oral mesalamine (<2.5 g/day), sulfasalazine (<3.0 g/day) or olsalazine (<1.5 g/day) on a stable dose for at least 2 weeks before randomization.
  9. Male and female subjects of childbearing potential must agree to avoid pregnancy throughout the duration of the study (defined as the time of the signing of the informed consent through the conclusion of subject participation). A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.

    • Women of childbearing potential (WOCBP) must have a negative urine pregnancy test result at screening. WOCBP are defined as women who are biologically capable of becoming pregnant, including women who are using contraceptives or whose sexual partners are either sterile or using contraceptives.
    • Women of non-childbearing potential (WONCBP) do not require a urine pregnancy test and must meet at least one of the following criteria:

      • Have undergone hysterectomy or bilateral oophorectomy;
      • Have medically confirmed ovarian failure or are medically confirmed to be post-menopausal (cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; laboratory confirmation of Follicle-stimulating hormone (FSH) level may be indicated if subject has history of amenorrhea for ≥ 52 weeks).
      • Are medically confirmed to be post-menopausal (cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; laboratory confirmation of FSH level may be indicated if subject has history of amenorrhea for ≥ 52 weeks).

Exclusion Criteria:

  1. Subjects with a diagnosis of indeterminate colitis or Crohn’s disease. Subjects with clinical findings suggestive of Crohn’s disease, e.g., fistulae or granulomas on biopsy are also excluded.
  2. Subjects with colonic dysplasia or neoplasia.
  3. Subjects with a history of colonic or small bowel obstruction or resection, except for appendectomy.
  4. Use of rectal 5-aminosalicylic acid or systemic or rectal corticosteroids within 30 days before baseline, use of immunosuppressive agents within 12 weeks before baseline.
  5. Use of antitumor necrosis factor (anti-TNFα) or anti-integrin therapy for UC at any moment of previous patient history 6. Repeated use of non-steroidal anti-inflammatory drugs (NSAIDs), including the non-steroidal anti-inflammatory drugs such as aspirin or ibuprofen (except for prophylactic use of a stable dose of aspirin up to 325 mg / day for cardiac disease). Occasional use of NSAIDs is permitted.

8. Subjects who had received another investigational agent within 30 days before baseline.

9. Any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, immunologic, or local active infection/infectious illness) that, in the investigator’s judgement will substantially increase the risk to the subject if he or she participates in the study.

10. Women during pregnancy or lactation.

VSL#3 for Ulcerative Colitis

Ulcerative colitis is a chronic disease that characteristically comes and goes. Depending on how you manage your diet, the symptoms will range from intense to remission. There have been some studies which show that probiotics can help keep Ulcerative Colitis in the remittance stage.

The probiotic VSL3 is a probiotic medical food that has such a high potency which ensures it will colonize in the gut. This potent probiotic is actually considered a Medical Grade Food.The greater potency ensures that the bacteria will survive through the stomach acid and bile. This product has 112 billion to 450 billion bacteria strains per serving.

Research shows that VSL3 probiotic can be helpful for Dietary Management of Ulcerative Colitis. One such study was published in the Korean Journal of Gastroenterology in 2012. The aim of the study was to assess the efficacy of VSL#3 on clinical response

Twenty-four patients with mild to moderate Ulcerative Colitis received VSL#3 daily in 2 divided doses for 8 weeks. The disease activity pre- and post-VSL#3 therapy was assessed by ulcerative colitis disease activity score. The patients were scored before treatment started and again after 8 weeks.

Results showed a remission in 45.8% of subjects, partial response in 20.8%, no change or worse in 25.0%. The mean ulcerative colitis disease activity index (UCDAI) scores decreased from 7.09 to 1.45 in patients with a remission.

VSL#3 probiotic is not just a dietary supplement, it’s actually a medical food. Why is that you might wonder? There are different criteria which need to be met for medical foods and supplements.

What are the criteria for Medical Grade Food?

  • It’s formulated to provide nutritional support for those with medical conditions. Simply modifying your diet alone will not be enough.
  • Ingredients should be Generally Recognized as Safe (GRAS) by qualified experts
  • Nutritional requirements are based on recognized scientific principles
  • Formulated to be used under medical supervision
  • Formulated for patients requiring medical care on a recurring basis

A new super protective probiotic for IBD

This study is looking at the role of bacteria in Inflammatory Bowel Disease.

2015

At the end of this project we shall be in a position to generate a ‘super-protective’ strain of Bifidobacteria and prepare it for test in patients with IBD.

What did this research look at?

People with Crohn’s Disease and Ulcerative Colitis have a different make-up of the

bacteria living in their gut compared to healthy people. Probiotics, or beneficial bacteria, offer a potentially safe treatment option for people with Crohn’s and Colitis, but varying results have been seen in clinical trials.

In active Crohn’s Disease and Ulcerative Colitis, inflammation damages the cells that line the gut allowing microbes and toxins to enter, further advancing the disease.

Bifidobacterium is a beneficial gut bacteria that helps protects the cells lining the gut from damage caused by inflammation. People with Inflammatory Bowel Disease have less of this bacteria in their gut compared to healthy people. The researchers also developed a new technique for screening bacteria. Other researchers will be able to use this technique to identify bacteria with similar protective properties to Bifidobacterium. Finding these bacteria could lead to more potential treatment options for people with Crohn’s and Colitis.

This research project aimed to identify how Bifidobacterium protects the gut from inflammation.

Conclusions

The researchers identified many properties of Bifidobacterium that allow it to protect against inflammation. Most importantly they found that Bifidobacterium releases a number of biological compounds that can reduce inflammation.

What do researchers think this could this mean for people with IBD?

The researchers hope this project will lead to new treatments for people with Crohn’s and Colitis. They plan to continue this research by developing treatments that target the compounds released by Bifidobacterium as a way to reduce the damaging effects of inflammation in people with Crohn’s and Colitis.

Who is leading the research: Dr Lindsay J Hall, Quadram Institute Bioscience

Our Funding: £119,018 (£68k funded by donation from Rick Parfitt Jr Foundation)

Duration: 24 months

Official title of the application: Identification of the structural and molecular components of Bifidobacteria that have epithelial protective effects: Towards development of effective bacterial therapy for IBD

Tags: Bacteria / Probiotics

Her gastroenterologist prescribes an aggressive round of steroids, antibiotics, and immune-suppressing drugs. After one month, her symptoms subside significantly; her doctor begins weaning her from the steroids; and she completes her antibiotic treatment. But there’s one remaining concern: She’s lost 5 lbs on her already-thin frame. While she no longer experiences pain, she’s not tolerating all foods well and is anemic, so her gastroenterologist refers her to an RD.

Upon initial assessment, the RD notes that Wendy is about 15 lbs underweight, and has dry, listless hair and a pale pallor. Her diet history shows virtually no raw fruits and vegetables or dairy and that she avoids wheat and most grains. Primarily, she eats plain grilled or boiled chicken, scrambled eggs, white rice, potatoes, and cooked carrots. Each day, Wendy drinks about three cups of black coffee, regular soda, and water. She also takes an iron-containing multivitamin/mineral supplement daily.

Recognizing that Wendy suffers from malnutrition, her RD works with her to develop a list of foods she likes and can tolerate, including foods to help boost her iron stores. Working from this list, Wendy creates a menu, adding one new nutrient-dense food every three days to expand her diet and check for tolerance.

Beginning with well-cooked vegetables, the RD expands Wendy’s repertoire to include a wider variety of fruits and vegetables, being careful to avoid those in the cruciferous family, which frequently cause gas. She recommends that Wendy include a high-quality yogurt with multiple strains of beneficial bacteria twice per day. She also suggests eliminating caffeine-containing foods to avoid overstimulating the gut.

After one month of improvement and consulting Wendy’s GI doctor, the RD adds a probiotic supplement to Wendy’s daily regimen. Along with her physician’s care plan, this new dietary intervention helps Wendy raise her diet’s nutrient density, control her anemia, and avoid a flareup of her ulcerative colitis for more than six months.

Story Behind Probiotics
Probiotics aren’t a new concept. Foods that contain friendly bacteria and yeast to cure and extend shelf life, and produce alcohol have been enjoyed for centuries and can be found in virtually all civilizations around the globe. Many of these foods have been touted as having all sorts of health benefits, and over the last few decades, researchers have begun to uncover convincing study findings about the health-supporting activities of these substances.

Moreover, we have a better understanding of the symbiotic relationship between bacteria and humans. According to the National Institutes of Health’s Human Microbiome Project, the human body hosts more than 10 times the number of bacteria as the number of cells. These bacteria cover the entire body, but perhaps the most diverse population is found within the GI tract, where they help digest food, generate vitamins, and combat pathogens.

Probiotics are defined as live microorganisms that provide positive health effects in the host that consumes adequate amounts.1 The health benefits of probiotics are realized through various mechanisms of action, such as creating a balance between beneficial bacteria and pathogens, reducing inflammation in the gut, and the downregulation of immune markers.

With more than 10,000 different microorganisms identified in the human body, it’s essential to remember that strain and dose are important factors when considering the application of probiotics.

Probiotics are used in the treatment and management of inflammatory bowel disease (IBD), which includes a variety of GI diseases, such as Crohn’s disease and ulcerative colitis. Both Crohn’s disease and ulcerative colitis result in similar GI symptoms, including pain, diarrhea, stools with mucus or blood, and ulceration or tissue damage within the alimentary canal. Nutrient deficiencies and malnutrition that can lead to underweight also may occur as well as headaches, fatigue, and anemia.

The defining differences between Crohn’s disease and ulcerative colitis are the location where ulceration and tissue damage occurs as well as the pattern and type of inflammation. Typically, ulceration in ulcerative colitis is limited to the colon, while Crohn’s disease most often occurs in the small intestine. However, overlap sometimes occurs between the two areas of the GI tract.

An IBD diagnosis may take months or even years until symptoms develop and testing is completed.

Role of Probiotics in IBD Sufferers
Treatment for IBD, as in Wendy’s case, includes a battery of medications, such as anti-inflammatories, steroids, antibiotics, and immunosuppressants. As with all medications, there are negative side effects, including the potential for antibiotic-induced diarrhea, anemia, and an increased risk of osteopenia. Preventing relapse is as important as treating acute occurrences of flareups in IBD. Stress management also is an important consideration for managing the disease.

According to one well-regarded theory, the cause or perpetuation of IBD results from an unbalanced microbiome in the gut.2 This theory implies that the use of probiotics may help rebalance the gut flora in a positive way, shifting from pro- to anti-inflammatory.

Research and Recommendations
Research on probiotics and IBD treatment is dynamic, and with so many strains of bacteria to study, the body of knowledge will continue to rise exponentially over the next decade. According to a recent review, conflicting data and a lack of sufficiently rigorous studies on Crohn’s disease haven’t yielded enough evidence to support or reject probiotic use for this condition.2 However, the report says results of probiotic use in ulcerative colitis have shown enough positive results to make it a promising part of many clinicians’ recommendations.2 The most positive research has been conducted in treating pouchitis, the inflammation that occurs in the pouch created to control stools after a partial colectomy has been performed to treat ulcerative colitis.

The World Gastroenterology Organization Practice Guidelines for the Diagnosis and Management of IBD in 2010 specifically address probiotics but state that their use isn’t supported in the literature for Crohn’s disease or ulcerative colitis. Yet the guidelines for the treatment of pouchitis recognize that research has shown a benefit with the use of specific bacterial strains, such as E coli Nissle 1917, and with the potent probiotic supplement VSL#3.

The American Society for Nutrition released guidelines that support the use of probiotics for ulcerative colitis and pouchitis patients based on research that showed effectiveness with E coli Nissle 1917 and VSL#3 that contains eight strains of bacteria.3 However, the society states the research doesn’t support the use of probiotics in Crohn’s disease. An analysis of 41 studies published in 2012 to review probiotic use in adult IBD patients supported these findings as well.4

Most research has been conducted in adults with IBD; however, the American Academy of Pediatrics addressed this treatment for children and stated that the research doesn’t support probiotic use in children because of unconvincing results and a lack of studies, including adequate numbers of children participating in the studies.5

One significant limiting factor in the research is the lack of rigor among studies. Few studies have included enough subjects, leading to inconclusive findings or results researchers can’t generalize. In addition, the number of potential beneficial bacteria and the challenge of determining how they benefit the human host make it more difficult to reach a consensus on recommendations for specific strains and dosing.

Research also has been done at different phases of disease activity, which makes comparing results more difficult. Some bacteria have shown a positive impact in maintaining remission but not in controlling symptoms during active disease. One positive is that the research has indicated that a very low risk of adverse effects is associated with the use of probiotics in IBD patients. More research is needed to identify what strains and doses may benefit these patients.

Incorporating Probiotics in the Diet
Probiotics are found in a variety of foods, with yogurt perhaps being most popular. Kefir is another great choice that includes many more strains of bacteria than yogurt, perhaps extending health benefits. More unusual probiotic sources include fermented foods such as kimchi, kombucha, and sauerkraut. Some pickled foods are fermented with bacteria.

As probiotics have become more popular, products such as probiotic-fortified juices, chocolates, and even peanut flour have become available, offering nondairy alternatives for clients with milk allergies or lactose intolerance.

For IBD patients, probiotic supplements may be considered since they have good potential and a low risk of adverse effects. Cost can be a barrier, however, since medical insurance generally won’t cover these supplements.

When considering supplements, it’s important to understand which strains of live bacteria are recommended for patients to purchase. Dietitians should work with the client’s physician to ensure they’re aware and supportive of this treatment.

Some bacteria that have been studied in humans for their potential clinical relevancy in ulcerative colitis, Crohn’s disease, and pouchitis are listed below. These bacteria, along with probiotics, were delivered via a supplement with or without standard medical treatment or after medically induced remission2:

• Ulcerative colitis: E coli Nissle 1917; VSL#3, a blend of bacteria to include Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium infantis, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus casei, Lactobacillus bulgaricus, Streptococcus thermophile; Lactobacillus boulardi; and Lactobacillus rhamnosis GG

• Crohn’s disease: L boulardi, L rhamnosis GG, Lactobacillus johnsonii, and VSL#3 (Probiotics haven’t shown significant benefit in Crohn’s disease, with most studies having too few subjects and showing no statistical difference in outcomes compared with controls.)

• Pouchitis: VSL#3 and Lactobacillus GG

This list should help nutrition professionals develop a framework for beginning the conversation about probiotics use in IBD patients. It’s important to remember that different strains provide different positive benefits and have been shown to have clinically unique relevance with regard to treating Crohn’s disease vs. ulcerative colitis. It’s suggested that nutrition professionals research the appropriate strain for recommended dosing information and remain connected as an interdisciplinary part of the patient’s healthcare team.

As probiotics are added to the diet in supplement or food form, patients must consume them regularly. Loss of beneficial bacteria through bowel movements necessitates constant replacement of those bacteria. In addition, bacteria need food to survive, so consider including prebiotics, which are substances that serve as fuel for probiotic bacteria. Prebiotics include inulin, fructo-oligosaccharides, and resistant starch, which may be added to foods such as yogurt, high-fiber snack bars, cereals, and granola.6

Much to Learn
It’s important to recognize that the research in this area is limited and emerging. While probiotics seem to have great potential for IBD patients, the current research doesn’t fully support their use. However, they seem to show the most promise in helping to maintain remission in ulcerative colitis once it has been achieved through traditional pharmacologic intervention and as an adjunctive treatment for pouchitis. More research is needed to determine what strains and at what dose probiotics become most useful as part of clinical intervention. Probiotics should be carefully considered as part of an overall care plan that includes medication, nutrition intervention, and lifestyle management.

— Sherry Coleman Collins, MS, RD, LD, is an Atlanta-based dietitian who has worked in clinical pediatrics and school foodservice, where she gained hands-on experience working with students, families, and staff to manage food allergies.

1. Sanders ME. Probiotics: definition, sources, selection, and uses. Clin Infect Dis. 2008;46 Suppl 2:S58–61.

3. Haller D, Antione JM, Bengmark S, Enck P, Rijkers GT, Lenoir-Wijnkoop I. Guidance for substantiating the evidence for beneficial effects of probiotics: probiotics in chronic inflammatory bowel disease and the functional disorder irritable bowel syndrome. J Nutr. 2010;140(3):690S-697S.

4. Jonkers D, Penders J, Masclee A, Pierik M. Probiotics in the management of inflammatory bowel disease: a systematic review of intervention studies in adult patients. Drugs. 2012;72(6):803-823.

5. Thomas DW, Greer FR; American Academy of Pediatrics Committee on Nutrition; American Academy of Pediatrics Section on Gastroenterology, Hepatology, and Nutrition. Probiotics and prebiotics in pediatrics. Pediatrics. 2010;126(6):1217-1231.

6. Douglas LC, Sanders ME. Probiotics and prebiotics in dietetics practice. J Am Diet Assoc. 2008;108(3):510-521.

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