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Pouchitis is the major long-term complication after ileal-pouch anal anastomosis for ulcerative colitis. Broad-spectrum antibiotics are the mainstay of treatment in this condition. Recently, we have shown the efficacy of a highly concentrated probiotic preparation (VSL#3, 900 billions/sachet lyophilized viable bacteria) in preventing relapses of chronic pouchitis and in preventing pouchitis onset. This study was designed to evaluate the efficacy of high-dose VSL#3 in the treatment of mildly active pouchitis.Twenty-three consecutive patients with mild pouchitis, defined as a score of between 7 and 12 in the Pouchitis Disease Activity Index, which includes clinical, endoscopic, and histological criteria, were treated with VSL#3, 2 sachetsb.i.d.(3600 billion bacteria/day) for four weeks. Symptomatic, endoscopic, and histologic evaluations were undertaken before and after treatment according to Pouchitis Disease Activity Index. Remission was defined as a combination of a Pouchitis Disease Activity Index clinical score of ≤2, endoscopic score of ≤1, and total Pouchitis Disease Activity Index score of ≤4. Patients in remission after treatment were treated with VSL#3, 1 sachetb.i.d.(1800 billion bacteria), as maintenance treatment for six months. The quality of life was assessed with the Inflammatory Bowel Disease Questionnaire.Sixteen of 23 patients (69 percent) were in remission after treatment. The median total Pouchitis Disease Activity Index scores before and after therapy were 10 (range, 9-12) and 4 (range, 2-11), respectively (P< 0.01). The median Inflammatory Bowel Disease Questionnaire score also significantly improved from 110 (range, 90-140) to 200 (range, 95-220;P< 0.001). All 16 patients who went into remission maintained remission during maintenance treatment. Only one patient experienced a transient bloating at the beginning of treatment.High doses of the probiotic VSL#3 are effective in the treatment of mild pouchitis. Further controlled studies are warranted.