Ciprofloxacin for the prevention of postoperative recurrence in patients with crohn's disease: A randomized, double-blind, placebo-controlled pilot study

Hans H. Herfarth, Jeffry A. Katz, Stephen B. Hanauer, William J. Sandborn, Edward V. Loftus, Bruce E. Sands, Joseph A. Galanko, Dolly Walkup, Kim L. Isaacs, Christopher F. Martin, Robert S. Sandler, Ryan B. Sartor

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32 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)1073-1079
Number of pages7
JournalInflammatory bowel diseases
Volume19
Issue number4
DOIs
StatePublished - Mar 1 2013

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Keywords

  • Anti-infective agents/adverse effects
  • Ciprofloxacin
  • Crohn's disease/surgery
  • Inflammatory bowel diseases
  • Quinolone

ASJC Scopus subject areas

  • Immunology and Allergy
  • Gastroenterology

Cite this

Herfarth, H. H., Katz, J. A., Hanauer, S. B., Sandborn, W. J., Loftus, E. V., Sands, B. E., Galanko, J. A., Walkup, D., Isaacs, K. L., Martin, C. F., Sandler, R. S., & Sartor, R. B. (2013). Ciprofloxacin for the prevention of postoperative recurrence in patients with crohn's disease: A randomized, double-blind, placebo-controlled pilot study. Inflammatory bowel diseases, 19(4), 1073-1079. https://doi.org/10.1097/01.MIB.0000428910.36091.10