Although the probiotic Saccharomyces cerevisiae I-3856 failed to improve symptoms overall in a cohort of patients with irritable bowel syndrome in a randomized controlled trial, subgroup analysis showed it improved abdominal pain and bloating in patients with constipation-predominant IBS.
“Due to the lack of suitable pharmacological treatments, there is growing interest in alternative all-natural solutions for long-term management of IBS,” Amélie Cayzeele Decherf, clinical studies specialist at Lesaffre Human Care, Lesaffre Group, Marcq en Baroeul, France, told Healio Gastroenterology, adding that Saccharomyces cerevisiae I-3856 “may be a new safe strategy to improve quality of life in people suffering from abdominal pain.”
Amélie Cayzeele Decherf
cerevisiae I-3856 is a strain from Lesaffre baker’s yeast collection, and like most yeasts, it “secretes numerous saccharolytic enzymes which may assist the intestinal microbiota in generating short chain fatty acids ... and alcohols which are known to exert a prokinetic effect at least in the small intestine,” Decherf and colleagues wrote. “Preliminary data from the first randomized placebo-controlled trial ... of S. cerevisiae I-3856 at the dose of 500 mg daily, in 179 unselected IBS patients, showed a significantly higher proportion of responders achieving a 50% reduction in average pain score in the active group compared to the placebo group in the last 4 weeks of treatment.”
To confirm these findings using a larger dose and a larger, more carefully phenotyped cohort, researchers performed a multicenter, randomized, double blind, placebo-controlled trial involving 379 patients who received 1,000 mg of the probiotic (n = 192) or placebo (n = 187) daily for 12 weeks, throughout which they completed questionnaires reporting data on symptoms, stool characteristics, well-being and quality of life. Most patients had constipation-predominant IBS (IBS-C; 47%).
The proportion of responders defined as experiencing a 50% reduction in weekly average abdominal pain or discomfort for at least 4 of the last 8 weeks of the study served as the primary endpoint.
Overall, 26.9% of the placebo group and 32.2% of the treatment group were considered responders, but the probiotic was not a significant predictor of response (P > .05). However, there was a significant treatment effect in IBS-C patients, with greater improvements in abdominal pain or discomfort and bloating in those treated with the probiotic compared with placebo at the end of the supplementation period (both P = .03). These benefits were also observed throughout the study (P = .04 and P = .01, respectively).
No serious adverse events related to the research or study probiotic occurred, and 16 possibly related adverse events occurred, including constipation, abdominal pain and gastroesophageal reflux.
“Although there was no effect of S. cerevisiae supplementation on IBS symptoms and quality of life in the total population, S. cerevisiae I-3856 improved gastrointestinal symptoms in the subgroup with constipation,” the researchers wrote. “Future studies should examine the underlying mechanisms, particularly the changes in small bowel transit to enable better targeting of treatment to patients who will benefit.” – by Adam Leitenberger
Disclosures: Decherf is employed by Lesaffre. Please see the full study for a list of all other researchers’ relevant financial disclosures.