title: Ineffectiveness of Lactobacillus johnsonii LA1 for prophylaxis of postoperative recurrence in Crohn's disease: a randomised, double blind, placebo controlled GETAID trial.
abstract: OBJECTIVE
  Early endoscopic recurrence is frequent after intestinal resection for Crohn's disease. Bacteria are involved, and probiotics may modulate immune responses to the intestinal flora. Here we tested the probiotic strain Lactobacillus johnsonii LA1 in this setting.
  
  
  METHODS
  This was a randomised, double blind, placebo controlled study. Patients were eligible if they had undergone surgical resection of <1 m, removing all macroscopic lesions within the past 21 days. Patients were randomised to receive two packets per day of lyophilised LA1 (2 x 10(9) cfu) or placebo for six months; no other treatment was allowed. The primary endpoint was endoscopic recurrence at six months, with grade >1 in Rutgeerts' classification or an adapted classification for colonic lesions. Endoscopic score was the maximal grade of ileal and colonic lesions. Analyses were performed primarily on an intent to treat basis.
  
  
  RESULTS
  Ninety eight patients were enrolled (48 in the LA1 group). At six months, endoscopic recurrence was observed in 30/47 patients (64%) in the placebo group and in 21/43 (49%) in the LA1 group (p = 0.15). Per protocol analysis confirmed this result. Endoscopic score distribution did not differ significantly between the LA1 and placebo groups. There were four clinical recurrences in the LA1 group and three in the placebo group.
  
  
  CONCLUSIONS
  L johnsonii LA1 (4 x 10(9) cfu/day) did not have a sufficient effect, if any, to prevent endoscopic recurrence of Crohn's disease.
authors.affiliation: Départment Gastroenterology, Hôpital Européen Georges Pompidou, Paris, France. philippe.marteau@lrb.aphp.fr
authors.forename: P
authors.initials: P
authors.lastname: Marteau
authors.forename: M
authors.initials: M
authors.lastname: Lémann
authors.forename: P
authors.initials: P
authors.lastname: Seksik
authors.forename: D
authors.initials: D
authors.lastname: Laharie
authors.forename: J F
authors.initials: JF
authors.lastname: Colombel
authors.forename: Y
authors.initials: Y
authors.lastname: Bouhnik
authors.forename: G
authors.initials: G
authors.lastname: Cadiot
authors.forename: J C
authors.initials: JC
authors.lastname: Soulé
authors.forename: A
authors.initials: A
authors.lastname: Bourreille
authors.forename: E
authors.initials: E
authors.lastname: Metman
authors.forename: E
authors.initials: E
authors.lastname: Lerebours
authors.forename: F
authors.initials: F
authors.lastname: Carbonnel
authors.forename: J L
authors.initials: JL
authors.lastname: Dupas
authors.forename: M
authors.initials: M
authors.lastname: Veyrac
authors.forename: B
authors.initials: B
authors.lastname: Coffin
authors.forename: J
authors.initials: J
authors.lastname: Moreau
authors.forename: V
authors.initials: V
authors.lastname: Abitbol
authors.forename: S
authors.initials: S
authors.lastname: Blum-Sperisen
authors.forename: J Y
authors.initials: JY
authors.lastname: Mary
mesh_terms: D000328:Adult; D003113:Colonoscopy; D003424:Crohn Disease / Q000473:pathology / Q000517:prevention & control* / Q000601:surgery; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007778:Lactobacillus; D008297:Male; D019936:Probiotics / Q000009:adverse effects / Q000627:therapeutic use*; D055502:Secondary Prevention; D012720:Severity of Illness Index; D017211:Treatment Failure; D016896:Treatment Outcome