title: Saccharomyces boulardii does not prevent relapse of Crohn's disease.
abstract: OBJECTIVE
  Saccharomyces boulardii is a probiotic yeast that has been shown to have beneficial effects on the intestinal epithelial barrier and digestive immune system. There is preliminary evidence that S boulardii could be used to treat patients with Crohn's disease (CD). We performed a randomized, placebo-controlled trial to evaluate the effects of S boulardii in patients with CD who underwent remission during therapy with steroids or aminosalicylates.
  
  
  METHODS
  We performed a prospective study of 165 patients who achieved remission after treatment with steroids or salicylates; they were randomly assigned to groups given S boulardii (1 g/day) or placebo for 52 weeks. The primary end point was the percentage of patients in remission at week 52. Time to relapse, Crohn's disease activity index scores, and changes in parameters of inflammation were secondary end points.
  
  
  RESULTS
  CD relapsed in 80 patients, 38 in the S boulardii group (47.5%) and 42 in the placebo group (53.2%, a nonsignificant difference). The median time to relapse did not differ significantly between patients given S boulardii (40.7 weeks) vs placebo (39.0 weeks). There were no significant differences between groups in mean Crohn's disease activity index scores or erythrocyte sedimentation rates or in median levels of C-reactive protein. In a post hoc analysis, nonsmokers given S boulardii were less likely to experience a relapse of CD than nonsmokers given placebo, but this finding requires confirmation.
  
  
  CONCLUSIONS
  Although the probiotic yeast S boulardii is safe and well tolerated, it does not appear to have any beneficial effects for patients with CD in remission after steroid or salicylate therapies.
authors: Institut des Maladies de l'Appareil Digestif (IMAD), Gastroenterology Department, CIC, Inserm-04, CHU, University Hospital, Nantes, France. arnaud.bourreille@chu-nantes.fr
authors: Arnaud
authors: A
authors: Bourreille
authors: Guillaume
authors: G
authors: Cadiot
authors: Gérard
authors: G
authors: Le Dreau
authors: David
authors: D
authors: Laharie
authors: Laurent
authors: L
authors: Beaugerie
authors: Jean-Louis
authors: JL
authors: Dupas
authors: Philippe
authors: P
authors: Marteau
authors: Patrick
authors: P
authors: Rampal
authors: Dominique
authors: D
authors: Moyse
authors: Ashraf
authors: A
authors: Saleh
authors: Marie-Emmanuelle
authors: ME
authors: Le Guern
authors: Jean-Paul
authors: JP
authors: Galmiche
mesh_terms: D000293:Adolescent; D000328:Adult; D000636:Aminosalicylic Acids / Q000008:administration & dosage; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage; D001691:Biological Therapy / Q000379:methods*; D003424:Crohn Disease / Q000517:prevention & control* / Q000628:therapy*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos / Q000008:administration & dosage; D019936:Probiotics / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D012440:Saccharomyces / Q000254:growth & development*; D055502:Secondary Prevention; D013256:Steroids / Q000008:administration & dosage; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000636:Aminosalicylic Acids; D000893:Anti-Inflammatory Agents; D010919:Placebos; D013256:Steroids
keywords: AE; C-reactive protein; CD; CDAI; CI; CRP; Crohn's disease; Crohn's disease activity index; ESR; IBD; Inflammatory Bowel Disease; Maintenance Therapy; Microbiota; OR; PP; adverse event; confidence interval; erythrocyte sedimentation rate; inflammatory bowel disease; mITT; modified intent-to-treat; odds ratio; per-protocol