title: Saccharomyces cerevisiaeCNCM I-3856 in irritable bowel syndrome: An individual subject meta-analysis.
abstract: OBJECTIVE
  To confirm previous conclusions onSaccharomyces 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 ofS. cerevisiaeCNCM 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. cerevisiaeCNCM 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 andP= 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.vs2.58 ± 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.vsPlacebo group: 2.59 ± 1.017 a.u.,P= 0.0009).
  
  
  CONCLUSIONS
  This meta-analysis supports previous data linkingS. cerevisiaeI-3856 and improvement of GI symptoms, in IBS overall population and in the IBS-C and IBS-C ≥ 2 subpopulations.
authors.affiliation: Amélie Cayzeele-Decherf, Fanny Pélerin, Peter Jüsten, Lesaffre Human Care, Lesaffre Group, 59700 Marcq en Baroeul, France.
authors.forename: Amélie
authors.initials: A
authors.lastname: Cayzeele-Decherf
authors.affiliation: Amélie Cayzeele-Decherf, Fanny Pélerin, Peter Jüsten, Lesaffre Human Care, Lesaffre Group, 59700 Marcq en Baroeul, France.
authors.forename: Fanny
authors.initials: F
authors.lastname: Pélerin
authors.affiliation: Amélie Cayzeele-Decherf, Fanny Pélerin, Peter Jüsten, Lesaffre Human Care, Lesaffre Group, 59700 Marcq en Baroeul, France.
authors.forename: Sébastien
authors.initials: S
authors.lastname: Leuillet
authors.affiliation: Amélie Cayzeele-Decherf, Fanny Pélerin, Peter Jüsten, Lesaffre Human Care, Lesaffre Group, 59700 Marcq en Baroeul, France.
authors.forename: Benoit
authors.initials: B
authors.lastname: Douillard
authors.affiliation: Amélie Cayzeele-Decherf, Fanny Pélerin, Peter Jüsten, Lesaffre Human Care, Lesaffre Group, 59700 Marcq en Baroeul, France.
authors.forename: Béatrice
authors.initials: B
authors.lastname: Housez
authors.affiliation: Amélie Cayzeele-Decherf, Fanny Pélerin, Peter Jüsten, Lesaffre Human Care, Lesaffre Group, 59700 Marcq en Baroeul, France.
authors.forename: Murielle
authors.initials: M
authors.lastname: Cazaubiel
authors.affiliation: Amélie Cayzeele-Decherf, Fanny Pélerin, Peter Jüsten, Lesaffre Human Care, Lesaffre Group, 59700 Marcq en Baroeul, France.
authors.forename: Gunnard K
authors.initials: GK
authors.lastname: Jacobson
authors.affiliation: Amélie Cayzeele-Decherf, Fanny Pélerin, Peter Jüsten, Lesaffre Human Care, Lesaffre Group, 59700 Marcq en Baroeul, France.
authors.forename: Peter
authors.initials: P
authors.lastname: Jüsten
authors.affiliation: Amélie Cayzeele-Decherf, Fanny Pélerin, Peter Jüsten, Lesaffre Human Care, Lesaffre Group, 59700 Marcq en Baroeul, France.
authors.forename: Pierre
authors.initials: P
authors.lastname: Desreumaux
mesh_terms: D015746:Abdominal Pain / Q000188:drug therapy / Q000209:etiology; D000328:Adult; D001691:Biological Therapy / Q000379:methods*; D003248:Constipation / Q000188:drug therapy / Q000209:etiology; D003672:Defecation / Q000187:drug effects; D005260:Female; D005414:Flatulence / Q000188:drug therapy / Q000209:etiology; D006801:Humans; D043183:Irritable Bowel Syndrome / Q000150:complications / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D019936:Probiotics / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D012441:Saccharomyces cerevisiae / Q000502:physiology*; D016896:Treatment Outcome
keywords: Abdominal pain; Constipation; Irritable bowel syndrome; Probiotics; Saccharomyces cerevisiae