title: Ornidazole for prophylaxis of postoperative Crohn's disease recurrence: a randomized, double-blind, placebo-controlled trial.
abstract: OBJECTIVE
  Crohn's disease almost inevitably recurs after ileocolonic resection, and effective prophylactic therapy has not been identified. We investigated the efficacy and safety of ornidazole, a nitroimidazole antibiotic, for the prevention of clinical recurrence of Crohn's disease after curative ileocolonic resection in a placebo-controlled double-blind clinical trial.
  
  
  METHODS
  Eighty patients were randomized to ornidazole 1 g/day or placebo started within 1 week of resection and continued for 1 year. The primary end point was the proportion of patients with clinical recurrence at 1 year. Secondary end points were endoscopic recurrence at 3 months and 12 months after resection.
  
  
  RESULTS
  Two patients in the ornidazole group withdrew consent and were not dosed. Ornidazole significantly reduced the clinical recurrence rate at 1 year from 15 of 40 (37.5%) patients in the placebo group to 3 of 38 (7.9%) patients in the ornidazole group (Fisher exact test, 8.03; P = .0046; odds ratio, 0.14; 95% confidence interval, 0.037-0.546). Ornidazole reduced endoscopic recurrence at 12 months from 26 of 33 (79%) in the placebo group to 15 of 28 (53.6%) in the ornidazole group (chi2 , 4.37; P = .037; odds ratio, 0.31; 95% confidence interval, 0.10-0.94). Endoscopic recurrence at 3 and 12 months predicted clinical recurrence. Significantly more patients in the ornidazole group dropped out from the study because of side effects (P = .041).
  
  
  CONCLUSIONS
  Ornidazole 1 g/day is effective for the prevention of recurrence of Crohn's disease after ileocolonic resection.
authors.affiliation: Department of Gastroenterology, University Hospital Gasthuisberg, 3000 Leuven, Belgium. Paul.Rutgeerts@uz.kuleuven.ac.be
authors.forename: Paul
authors.initials: P
authors.lastname: Rutgeerts
authors.forename: Gert
authors.initials: G
authors.lastname: Van Assche
authors.forename: Séverine
authors.initials: S
authors.lastname: Vermeire
authors.forename: Geert
authors.initials: G
authors.lastname: D'Haens
authors.forename: Filip
authors.initials: F
authors.lastname: Baert
authors.forename: Maja
authors.initials: M
authors.lastname: Noman
authors.forename: Isolde
authors.initials: I
authors.lastname: Aerden
authors.forename: Gert
authors.initials: G
authors.lastname: De Hertogh
authors.forename: Karel
authors.initials: K
authors.lastname: Geboes
authors.forename: Martin
authors.initials: M
authors.lastname: Hiele
authors.forename: Andre
authors.initials: A
authors.lastname: D'Hoore
authors.forename: Freddy
authors.initials: F
authors.lastname: Penninckx
mesh_terms: D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D003424:Crohn Disease / Q000000981:diagnostic imaging / Q000473:pathology / Q000517:prevention & control* / Q000601:surgery*; D004311:Double-Blind Method; D016099:Endoscopy, Gastrointestinal; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009950:Ornidazole / Q000009:adverse effects / Q000627:therapeutic use*; D011182:Postoperative Care; D011237:Predictive Value of Tests; D011859:Radiography; D055502:Secondary Prevention
chemical_list: D000900:Anti-Bacterial Agents; D009950:Ornidazole