Guillaume Pineton de Chambrun1, Christel Neut2, Amélie Chau3, Murielle Cazaubiel4, Fanny Pelerin5, Peter Justen5, Pierre Desreumaux6. 1. CHU Lille, Department of Gastroenterology, Claude Huriez Hospital, Lille, France; Lille University North of France, Lille, France; INSERM U995, Lille, France. 2. Lille University North of France, Lille, France; INSERM U995, Lille, France; Department of Microbiology, Faculty of Pharmacy, University of Lille, France. 3. Lille University North of France, Lille, France; INSERM U995, Lille, France; CHU Lille, Department of Surgery, Claude Huriez Hospital, Lille, France. 4. Biofortis-Mérieux NutriSciences, Nantes, France. 5. Lesaffre International, Lesaffre Human Care, France. 6. CHU Lille, Department of Gastroenterology, Claude Huriez Hospital, Lille, France; Lille University North of France, Lille, France; INSERM U995, Lille, France. Electronic address: pdesreumaux@hotmail.com.
Abstract
BACKGROUND: We aimed to evaluate clinical symptoms in subjects with irritable bowel syndrome receiving Saccharomyces cerevisiae in a randomized double-blind placebo-controlled clinical trial. METHODS: Overall, 179 adults with irritable bowel syndrome (Rome III criteria) were randomized to receive once daily 500 mg of Saccharomyces cerevisiae, delivered by one capsule (n = 86, F: 84%, age: 42.5 ± 12.5), or placebo (n = 93, F: 88%, age: 45.4 ± 14) for 8 weeks followed by a 3-week washout period. After a 2-week run-in period, cardinal symptoms (abdominal pain/discomfort, bloating/distension, bowel movement difficulty) and changes in stool frequency and consistency were recorded daily and assessed each week. A safety assessment was carried out throughout the study. RESULTS: The proportion of responders, defined by an improvement of abdominal pain/discomfort, was significantly higher (p = 0.04) in the treated group than the placebo group (63% vs 47%, OR = 1.88, 95%, CI: 0.99-3.57) in the last 4 weeks of treatment. A non-significant trend of improvement was observed with Saccharomyces cerevisiae for the other symptoms. Saccharomyces cerevisiae was well tolerated and did not affect stool frequency and consistency. CONCLUSION: Saccharomyces cerevisiae is well tolerated and reduces abdominal pain/discomfort scores without stool modification. Thus, Saccharomyces cerevisiae may be a new promising candidate for improving abdominal pain in subjects with irritable bowel syndrome.
RCT Entities:
BACKGROUND: We aimed to evaluate clinical symptoms in subjects with irritable bowel syndrome receiving Saccharomyces cerevisiae in a randomized double-blind placebo-controlled clinical trial. METHODS: Overall, 179 adults with irritable bowel syndrome (Rome III criteria) were randomized to receive once daily 500 mg of Saccharomyces cerevisiae, delivered by one capsule (n = 86, F: 84%, age: 42.5 ± 12.5), or placebo (n = 93, F: 88%, age: 45.4 ± 14) for 8 weeks followed by a 3-week washout period. After a 2-week run-in period, cardinal symptoms (abdominal pain/discomfort, bloating/distension, bowel movement difficulty) and changes in stool frequency and consistency were recorded daily and assessed each week. A safety assessment was carried out throughout the study. RESULTS: The proportion of responders, defined by an improvement of abdominal pain/discomfort, was significantly higher (p = 0.04) in the treated group than the placebo group (63% vs 47%, OR = 1.88, 95%, CI: 0.99-3.57) in the last 4 weeks of treatment. A non-significant trend of improvement was observed with Saccharomyces cerevisiae for the other symptoms. Saccharomyces cerevisiae was well tolerated and did not affect stool frequency and consistency. CONCLUSION:Saccharomyces cerevisiae is well tolerated and reduces abdominal pain/discomfort scores without stool modification. Thus, Saccharomyces cerevisiae may be a new promising candidate for improving abdominal pain in subjects with irritable bowel syndrome.