AN ANTIBIOTIC REGIMEN FOR THE TREATMENT OF ACTIVE CROHNS-DISEASE - A RANDOMIZED, CONTROLLED CLINICAL-TRIAL OF METRONIDAZOLE PLUS CIPROFLOXACIN

Objectives: Bacteria in the gut lumen may play a role in the etiology and/or the symptoms of Crohn's disease (CD). Although various antibact erial drugs have been employed in clinical practice, few controlled tr ials have been conducted, and those had conflicting results. The aim o f this study was to investigate the efficacy and the safety of a combi nation of metronidazole and ciprofloxacin, compared with methylprednis olone, in treating 41 consecutive patients with active CD. Methods: El igible patients, 13 men and 28 women, mean age 38 yr, were randomly al located to receive, for 12 wk, ciprofloxacin 500 mg twice daily plus m etronidazole 250 mg four times daily or methylprednisolone 0.7-1 mg/kg /day, with variable tapering to 40 mg, followed by tapering of 4 mg we ekly. Results: Ten of the 22 antibiotic patients (45.5%) and 12 of the 19 steroid patients (63 %) obtained clinical remission (Crohn's Disea se Activity Index less than or equal to 150) at the end of the 12-wk s tudy (p = NS). Five patients on antibiotics (22.7%) and five patients on steroids (26.3%) were considered treatment failures because of dete rioration or persistent symptoms. Six patients receiving antibiotics ( 27.3%) and two on steroids (10.6%) were withdrawn from the trial becau se of side effects. One patient on antibiotics was not compliant. Conc lusions: metronidazole and ciprofloxacin could be an alternative to st eroids in treating the acute phase of CD.