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Recently, clinical trials have shown that the bacterial strain Bifidobacterium infantis 35624, or Bifantis®, can benefit people with IBS and other conditions of the GI tract. This chapter will discuss the clinical trials with this probiotic strain that have been published in Gastroenterology (March 2005) and The American Journal of Gastroenterology (July 2006), and provide some insights into how this probiotic can be combined with other strategies to manage digestive upsets including IBS.

Benefits of Bifantis in Irritable Bowel Syndrome Two clinical efficacy trials were conducted on Bifantis for IBS. The first of these studies (considered a “pilot” study) compared the effects of two probiotic strains (Bifantis and Lactobacillus salivarius) on symptoms in patients with IBS.7 In this study, 77 IBS patients (both men and women) received Bifantis, L. salivarius, or placebo for eight weeks. Patients taking Bifantis had significantly more relief than the lactobacillus and placebo groups from each of the main symptoms of IBS (abdominal pain/discomfort, distension/bloating, and difficult bowel movement), and the Bifantis group had better quality of life. Furthermore, Bifantis was well tolerated and did not cause any adverse side effects. At the same time, stool frequency or form changed little, so the improvements could not be attributed to either a laxative or an anti-diarrheal effect. Equally significant, in the patients treated with Bifantis, the ratio of IL-10/ IL-12 (anti-inflammatory/ pro-inflammatory) cytokines increased, approaching that of the healthy volunteers, whereas there was no such change in theother treatment groups. The importance of these cytokines was discussed in Chapter 4.

The first study was followed by a larger, four week study of Bifantis in 362 female IBS patients between the ages of 18 and 65.16 Again, all of the symptoms of IBS (abdominal pain/discomfort, bloating, sense of incomplete evacuation, straining, urgency, passage of gas and mucus, and bowel habit satisfaction) significantly improved in the Bifantis group. Furthermore, a global assessment of IBS symptoms (a question that asks “Have you had adequate relief of your IBS symptoms, yes or no?”) at the end of therapy revealed a greater than 20 percent therapeutic benefit for Bifantis over placebo—the strongest therapeutic benefit in any IBS study, with any treatment, to date. Interestingly, patients taking Bifantis also had normalized bowel movement frequency, regardless of whether they started with very frequent (diarrhea) or very few (constipation) bowel movements. This appears to be a unique finding since other agents used or tested in IBS have tended to target only one type of IBS (diarrhea or constipation) but not work in both. Because these changes in bowel frequency were accompanied by significant improvement in the individual symptoms, such as pain and bloating, these findings indicate that the health benefits of Bifantis are not limited to any specific IBS subtype, but that it is effective for the entire spectrum of IBS patients. “We are pleased and excited with the results of this study, as it represents an advance in the treatment of IBS, which can cause such embarrassing symptoms, often on a daily basis,” said Dr. Peter Whorwell, Professor of Medicine and Gastroenterology at the University of Manchester (UK) and lead author of the study.