Saccharomyces cerevisiae CNCM I-3856 in irritable bowel syndrome: An individual subject meta-analysis
AIM To confirm previous conclusions on Saccharomyces cerevisiae(S. cerevisiae) CNCM I-3856 for irritable bowel syndrome(IBS) management.METHODS An individual patient data meta-analysis was performed on two randomized clinical trials studying the effect of S. cerevisiae CNCM I-3856 supplementation on...
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Published in | World journal of gastroenterology : WJG Vol. 23; no. 2; pp. 336 - 344 |
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Main Authors | , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
United States
Baishideng Publishing Group Inc
14.01.2017
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Subjects | |
Online Access | Get full text |
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Summary: | AIM To confirm previous conclusions on Saccharomyces cerevisiae(S. cerevisiae) CNCM I-3856 for irritable bowel syndrome(IBS) management.METHODS An individual patient data meta-analysis was performed on two randomized clinical trials studying the effect of S. cerevisiae CNCM I-3856 supplementation on gastrointestinal(GI) symptoms in IBS subjects. A total of 579 IBS subjects were included. Outcomes were the daily Likert scale scores of abdominal pain/discomfort and bloating [area under the curve(AUC) and weekly means], responder status, and bowel movements(stool frequency and consistency). Statistical analyses were conducted in Intent to Treat(ITT) population, IBS-C subjects and IBS-C subjects with an abdominal pain/discomfort score higher than or equal to 2 at baseline('IBS-C ≥ 2 subpopulation').RESULTS S. cerevisiae CNCM I-3856 significantly improved abdominal pain/discomfort and bloating during the second month of supplementation [AUC(W5-W8)]with improvement up to the minimal clinically relevant threshold of 10%: a 12.3% reduction of abdominal pain/discomfort in the ITT population compared to the Placebo group(P = 0.0134) has been observed. In the IBS-C ≥ 2 subpopulation, there were a 13.1% reduction of abdominal pain/discomfort and a 14.9% reduction of bloating compared to the Placebo group(P = 0.0194 and P = 0.0145, respectively). GI symptoms significantly decreased during supplementation but no statistical differences were reported between groups at the end of the supplementation period. Responder status was defined as a subject who experienced a decrease of 1 arbitrary unit(a.u.) or 50% of the abdominal discomfort score from baseline for at least 2 wk out of the last 4 wk of the study. A significant difference between groups was reported in the ITT population, when considering the first definition: subjects in the Active group had 1.510 higher odds to be a responder(reduction of 1 a.u. of abdominal pain/discomfort) compared with subjects in the Placebo group(P = 0.0240). At the end of supplementation period, stool consistency in the Active group of the ITT population was significantly improved and classified as 'normal' compared to Placebo(respectively 3.13 ± 1.197 a.u. vs 2.58 ± 1.020 a.u., P = 0.0003). Similar results were seen in the IBS-C ≥ 2 subpopulation(Active group: 3.14 ± 1.219 a.u. vs Placebo group: 2.59 ± 1.017 a.u., P = 0.0009).CONCLUSION This meta-analysis supports previous data linking S. cerevisiae I-3856 and improvement of GI symptoms, in IBS overall population and in the IBS-C and IBS-C ≥ 2 subpopulations. |
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Bibliography: | Amélie Cayzeele-Decherf;Fanny Pélerin;Sébastien Leuillet;Benoit Douillard;Béatrice Housez;Murielle Cazaubiel;Gunnard K Jacobson;Peter Jüsten;Pierre Desreumaux;Lesaffre Human Care, Lesaffre Group;Biofortis-Mérieux NutriS ciences,;Lesaffre Yeast Corporation, Lesaffre Group;CHU Lille, Department of Gastroenterology, Claude Huriez Hospital;Lille University North of France;INSERM U995 ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 Telephone: +33-3-20148320 Author contributions: All authors have made substantial contributions to conception and design of the study, acquisition of data, analysis and interpretation of data; Cayzeele-Decherf A, Leuillet S and Housez B have drafted the article and other authors have made critical revisions related to important intellectual content of the manuscript; All authors have been involved for final approval of the version of the article to be published. Correspondence to: Amélie Cayzeele-Decherf, Clinical Study Manager, Lesaffre Human Care, Lesaffre Group, 59700 Marcq en Baroeul, France. ace@lesaffre.fr |
ISSN: | 1007-9327 2219-2840 2219-2840 |
DOI: | 10.3748/wjg.v23.i2.336 |