Four-week open-label trial of metronidazole and ciprofloxacin for the treatment of recurrent or refractory pouchitis T. MIMURA*, F. RIZZELLO  , U. HELWIG  , G. POGGIOLI  , S. SCHREIBER à , I. C. TALBOT*, R. J. NICHOLLS*, P. GIONCHETTI  , M. CAMPIERI  & M. A. KAMM* *Departments of Medicine, Surgery and Pathology, St Mark’s Hospital, London, UK;  Departments of Internal Medicine, Gastroenterology and Surgery, University of Bologna, Bologna, Italy; and àFirst Department of Medicine, Christian- Albrechts-University, Kiel, Germany Accepted for publication 22 October 2001 Ó 2002 Blackwell Science Ltd 909 SUMMARY Background: Preliminary data suggest that short-term antibiotic therapy with a single drug is effective for the treatment of patients with pouchitis. However, some patients are resistant to treatment. Aim: To evaluate the therapeutic efficacy of a prolonged course of a combination of two antibiotics in patients with refractory or recurrent pouchitis, as well as its impact on their quality of life. Methods: Patients with active refractory or recurrent pouchitis were recruited. This was defined as both: (i) a history of pouchitis at least twice in the last 12 months or persistent pouchitis requiring continual intake of antibiotics; and (ii) a Pouchitis Disease Activity Index score 3 7 (best to worst pouchitis ¼ 0– 18) at the beginning of therapy. Treatment consisted of a combination of metronidazole, 400 or 500 mg twice daily, and ciprofloxacin, 500 mg twice daily, for 28 days. Symptomatic, endoscopic and histological evaluations were undertaken before and after antibi- otic therapy using the Pouchitis Disease Activity Index score. Remission was defined as a combination of a Pouchitis Disease Activity Index clinical score of 6 2, endoscopic score of 6 1 and total score of 6 4. The quality of life was assessed with the Inflammatory Bowel Disease Questionnaire, which encompasses bowel, systemic and emotional symptoms as well as social function (worst to best ¼ 32–224). Results: Forty-four patients (24 male, 20 female; median age, 37.5 years) entered the trial and completed treat- ment. Thirty-six (82%) went into remission. The median Pouchitis Disease Activity Index scores before and after therapy were 12 (range, 8–17) and 3 (range, 1–10), respectively (P < 0.0001). The median Inflammatory Bowel Disease Questionnaire score also significantly improved from 96.5 (range, 74–183) to 175 (range, 76–215) with this therapy (P < 0.0001). The eight patients (five male, three female) who did not go into remission were significantly older (median 47.5 vs. 35 years; P ¼ 0.007), had a longer history of pouchitis (95.5 vs. 26 months; P ¼ 0.0008), had a greater pro- portion with chronic pouchitis (chronic/relapsing: 6/2 vs. 9/27; relative risk, 1.6; 95% confidence interval, 1.0– 2.4) and tended to have a higher Pouchitis Disease Activity Index score before treatment (median 14.5 vs. 12; P ¼ 0.13) than those who went into remission. Even in these eight patients, the median Pouchitis Disease Activity Index score significantly improved from 14.5 (range, 8–16) to 9.5 (range, 7–10) (P ¼ 0.0078), as did the Inflammatory Bowel Disease Questionnaire score from 95.5 (range, 74–134) to 127 (range, 76–187) (P ¼ 0.039). The Inflammatory Bowel Disease Question- naire score strongly correlated with the Pouchitis Disease Activity Index score (r ¼ 0.79, P < 0.0001), and was significantly related to the patients’ overall assessment of satisfaction (P < 0.0001). No serious side-effects were noted. Correspondence to: Professor M. A. Kamm, St Mark’s Hospital, Northwick Park, Watford Road, Harrow, Middlesex HA1 3UJ, UK. E-mail: kamm@ic.ac.uk Aliment Pharmacol Ther 2002; 16: 909–917.