High-dose probiotics for the treatment of active pouchitis.

PURPOSE: 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.

METHODS: 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 sachets b.i.d. (3,600 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 <or=2, endoscopic score of <or=1, and total Pouchitis Disease Activity Index score of <or=4. Patients in remission after treatment were treated with VSL#3, 1 sachet b.i.d. (1,800 billion bacteria), as maintenance treatment for six months. The quality of life was assessed with the Inflammatory Bowel Disease Questionnaire.

RESULTS: 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.

CONCLUSIONS: High doses of the probiotic VSL#3 are effective in the treatment of mild pouchitis. Further controlled studies are warranted.