Ciprofloxacin for the Prevention of Postoperative Endoscopic Recurrence in Crohn's Disease
Status:
Completed
Trial end date:
2011-12-01
Target enrollment:
Participant gender:
Summary
Despite extensive medical treatment, surgical resection is required in approximately 70% of
the patients at some time. However, recurrence of the disease after operation occurs in the
majority of patients and is a serious limitation of surgical management. Therapeutic options
to maintain postoperative clinical remission are urgently needed. Several drugs including
mesalazine, antibiotics (metronidazole, ornidazole) and azathioprine or 6-mercaptopurine have
been studied in the past. But the efficacy is very limited (mesalazine), overshadowed by
intolerability during long-term therapy (metronidazole, ornidazole) or inconclusive
(azathioprine or 6-mercaptopurine). Research demonstrating the absence of inflammation in
patients with diverting ileostomy and the clinical benefit of a postoperative antibiotic
therapy using metronidazole or ornidazole implicates a role of the resident bacterial flora
in the postoperative relapse. Ciprofloxacin has a broad antibacterial spectrum. More
interestingly it also suppresses E. coli strains, which can be found in high numbers in early
and chronic ileal lesions of Crohn's disease patients Ciprofloxacin has demonstrated
beneficial effects in the therapy of inflammatory bowel diseases, but the available data of
the effectiveness of ciprofloxacin allow only a very limited judgement of the safety and
tolerability of a 6 months therapy of ciprofloxacin. Therefore an exploratory multicenter
prospective, placebo-controlled trial is planned to analyze the safety and tolerability of a
6 months therapy with ciprofloxacin compared to placebo in 40 patients (randomly assigned in
a 1:1 ratio) undergoing ileocecal resection (or resection of parts of the colon). If this
therapeutic regimen demonstrates tolerability, a second larger study improving the
superiority of ciprofloxacin versus placebo can be initiated.
Phase:
Phase 2
Details
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborators:
Crohn's and Colitis Foundation National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)