title: Ciprofloxacin for the prevention of postoperative recurrence in patients with Crohn's disease: a randomized, double-blind, placebo-controlled pilot study.
abstract: BACKGROUND
  The commensal bacterial flora plays a critical role in the postoperative recurrence of Crohn's disease (CD). We conducted a randomized, double-blind, placebo-controlled 6-month pilot trial of ciprofloxacin for the prevention of endoscopic recurrence in patients with CD who underwent surgery.
  
  
  METHODS
  Thirty-three patients with CD, who had undergone surgery with ileocolonic anastomosis within the previous 2 weeks, were randomized to treatment with ciprofloxacin (500 mg twice daily) or placebo tablets for 6 months. Endpoints were endoscopic recurrence at 6 months and safety and tolerability of long-term ciprofloxacin therapy.
  
  
  RESULTS
  Thirty-three patients were randomized; 14 patients discontinued the study early. Significant endoscopic recurrence was observed in 3 of 9 patients (33%) in the ciprofloxacin group and 5 of 10 patients (50%) in the placebo group at 6 months after surgery (P < 0.578). The intention-to-treat analysis demonstrated endoscopic recurrence in 11 of 17 patients (65%) in the ciprofloxacin group and 11 of 16 patients (69%) in the placebo group at month 6 (P < 0.805). Thirty-six adverse events occurred in 19 of 33 patients (58%). Possible drug-associated adverse events occurred significantly more often in the ciprofloxacin group (P < 0.043), leading to study drug discontinuation in 24% (4 of 17) and 6% of patients (1 of 16) in the ciprofloxacin and placebo groups, respectively (P < 0.166).
  
  
  CONCLUSIONS
  In this pilot study, ciprofloxacin was not more effective than placebo for the prevention of postoperative recurrence in patients with CD. Long-term ciprofloxacin therapy is limited by drug-associated side effects. Future studies in postoperative prevention of CD should evaluate antibiotic approaches with a more favorable safety profile.
authors.affiliation: Division of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, North Carolina 27599, USA. hherf@med.unc.edu
authors.forename: Hans H
authors.initials: HH
authors.lastname: Herfarth
authors.forename: Jeffry A
authors.initials: JA
authors.lastname: Katz
authors.forename: Stephen B
authors.initials: SB
authors.lastname: Hanauer
authors.forename: William J
authors.initials: WJ
authors.lastname: Sandborn
authors.forename: Edward V
authors.initials: EV
authors.lastname: Loftus
authors.forename: Bruce E
authors.initials: BE
authors.lastname: Sands
authors.forename: Joseph A
authors.initials: JA
authors.lastname: Galanko
authors.forename: Dolly
authors.initials: D
authors.lastname: Walkup
authors.forename: Kim L
authors.initials: KL
authors.lastname: Isaacs
authors.forename: Christopher F
authors.initials: CF
authors.lastname: Martin
authors.forename: Robert S
authors.initials: RS
authors.lastname: Sandler
authors.forename: Ryan B
authors.initials: RB
authors.lastname: Sartor
mesh_terms: D000293:Adolescent; D000328:Adult; D000714:Anastomosis, Surgical; D000890:Anti-Infective Agents / Q000627:therapeutic use*; D002939:Ciprofloxacin / Q000627:therapeutic use*; D003424:Crohn Disease / Q000601:surgery*; D004311:Double-Blind Method; D004724:Endoscopy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D010865:Pilot Projects; D011183:Postoperative Complications / Q000517:prevention & control*; D011379:Prognosis; D055502:Secondary Prevention; D055815:Young Adult
chemical_list: D000890:Anti-Infective Agents; D002939:Ciprofloxacin