title: Multicenter randomized-controlled clinical trial of probiotics (Lactobacillus johnsonii, LA1) on early endoscopic recurrence of Crohn's disease after lleo-caecal resection.
abstract: BACKGROUND
  Seventy percent of Crohn's disease (CD) patients exhibit anastomotic recurrence within 1 year after ileo-caecal surgery. Recent clinical trials suggest the beneficial use of probiotics in the control of intestinal inflammation in pouchitis and ulcerative colitis. This study is a multicenter clinical trial evaluating the efficacy of an oral administration of the probiotic LAl on early post-operative endoscopic recurrence of CD.
  
  
  METHODS
  Seventy patients with CD were enrolled prior to elective ileo-caecal resection and randomly assigned after surgery to daily treatment with either Lactobacillus johnsonii, LA1, Nestle (1010 colony-forming units, CFU) (group A, n = 34) or placebo (group B, n = 36) for 12 weeks. The primary objective was to assess the effect of LAl on the endoscopic recurrence rate at 12 weeks. Stratification was performed according to smoking status at randomization.
  
  
  RESULTS
  Seven and 14 patients were excluded in the LA1 and placebo groups, respectively. In intention-to-treat analysis, the mean endoscopic score was not significantly different between the two treatment groups at 3 months (LA1 versus placebo: 1.50 +/- 1.32 versus 1.22+/-1.37, treatment effect: P = 0.48, smoke effect: P = 0.72). The percentage of patients with severe recurrence (i3 + i4) was 21% and 15% in the LAl and placebo groups, respectively (P = 0.33). Using a per-protocol (PP) analysis, the mean endoscopic score was not significantly different between the two treatment groups (LAl versus placebo groups: 1.44 +/-1.31 versus 1.05 +/- 1.21, P = 0.32). The percentage of patients with severe recurrence (i3 + i4) was 19% and 9% in the LAl and placebo groups, respectively (P = 0.054). Clinical relapse rate (CDAI [CD activity index] > 150, with an increase of CDAI > 70 points or greater from baseline) in the LAl and placebo groups was 15% (4/27) and 13.5% (3/22), respectively (PP analysis: chi-square test, P = 0.91 and log-rank test: P = 0.79).
  
  
  CONCLUSIONS
  Oral administration of the probiotic LA1 in patients with CD failed to prevent early endoscopic recurrence at 12 weeks after ileo-caecal resection.
authors.affiliation: Erasme University Hospital, ULB, Brussels, Belgium.
authors.forename: Andre
authors.initials: A
authors.lastname: Van Gossum
authors.forename: Olivier
authors.initials: O
authors.lastname: Dewit
authors.forename: Edouard
authors.initials: E
authors.lastname: Louis
authors.forename: Geert
authors.initials: G
authors.lastname: de Hertogh
authors.forename: Filip
authors.initials: F
authors.lastname: Baert
authors.forename: Fernand
authors.initials: F
authors.lastname: Fontaine
authors.forename: Martine
authors.initials: M
authors.lastname: DeVos
authors.forename: Marc
authors.initials: M
authors.lastname: Enslen
authors.forename: Marc
authors.initials: M
authors.lastname: Paintin
authors.forename: Denis
authors.initials: D
authors.lastname: Franchimont
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002432:Cecum / Q000601:surgery*; D003131:Combined Modality Therapy; D003424:Crohn Disease / Q000473:pathology / Q000601:surgery* / Q000628:therapy; D004311:Double-Blind Method; D016099:Endoscopy, Gastrointestinal; D005260:Female; D006801:Humans; D007082:Ileum / Q000601:surgery*; D007778:Lactobacillus; D008297:Male; D008875:Middle Aged; D019936:Probiotics / Q000627:therapeutic use*; D012008:Recurrence