Crohn’s disease almost inevitably recurs after ileocolonic resection, and effective prophylactic therapy has not been identified.
Dr Rutgeerts and colleagues from Belgium investigated the efficacy and safety of ornidazole, a nitroimidazole antibiotic, for the prevention of clinical recurrence of Crohn’s disease after curative ileocolonic resection.
The researchers conducted a placebo-controlled double-blind clinical trial where 80 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 set by the research team was the proportion of patients with clinical recurrence at 1 year.
In addition, the team considered secondary end points including endoscopic recurrence at 3 months and 12 months after resection.
| Endoscopic recurrence at 12 months was 54% in the ornidazole group versus 79% with placebo|
The investigators reported that 2 patients in the ornidazole group withdrew consent and were not dosed.
The team found that ornidazole significantly reduced the clinical recurrence rate at 1 year to 38% of patients in the placebo group and 8% of patients in the ornidazole group.
The researchers also observed that ornidazole reduced endoscopic recurrence at 12 months, with recurrence presenting in 79% of patients in the placebo group and 54% in the ornidazole group.
Endoscopic recurrence at 3 and 12 months predicted clinical recurrence.
The research team noted that significantly more patients in the ornidazole group dropped out from the study because of side effects.
Dr Rutgeert’s team concludes, “Ornidazole at 1 g/day is effective for the prevention of recurrence of Crohn’s disease after ileocolonic resection.”