Toshiki Mimura, University of Tokyo, Tokyo, Japan; Fernando Rizzello, University of Bologna, Bologna, Italy; Stephan Schreiber, Christian-Albrechts-University, Kiel, Germany; Ian C Talbot, R J Nicholls, St Mark’s Hospital, London, Uk; Paolo Gionchetti, Massimo Campieri, University of Bologna, Bologna, Italy; Michael A Kamm, St Mark’s Hospital, London, UK BACKGROUNDS AND
AIM: Most patients with acute pouchitis respond to antibiotics, but 10-15% experience recurrent or refractory pouchitis. This study aimed to evaluate the effectiveness of a probiotic therapy in maintaining the remission and quality of life (QOL) in these patients.
METHODS: Patients with active refractoryor recurrent pouchitis, who were successfully brought into remission by a 4week course of metronidazole and ciprofloxacin, were randomised into 2 groups:once daily VSL#3 6g or Placebo for one year or until relapse. VSL#3 is a probiotic preparation, containing 300 billion bacterial cells per gram of 4 strains of Lactobacilli, 3 strains of Bifidobacteria and one strain ofStreptococcus. Symptomatic, endoscopic and histological evaluations were made before and 2 and 12 months after the randomisation or at the time of relapse,using the Pouchitis Disease Activity Index (PDAI). Active refractory or recurrent pouchitis was defined as both PDAI score > 7 {range 0(perfect) to 18 (worst)} and either a history of pouchitis at least twice inthe previous one year or persistent pouchitis requiring continual intake ofantibiotics. Remission was defined as clinical PDAI score < 2 andendoscopic PDAI score < 1. Relapse was defined as the increaseof clinical PDAI score > 2 and the increase ofendoscopic PDAI score > 3 compared to the baselinescore at entry. QOL was assessed with the Inflammatory Bowel Disease Questionnaire (IBDQ).
RESULTS: Thirty-six patients (18 Male; median 36 years old) were randomised: 20 on VSL#3 and 16 on Placebo. 2 patients(10%) on VSL#3 relapsed, while 15 (94%) on placebo relapsed during the one-year study (p<0.0001: logrank test). In the 17 patients who remained in remission on VSL#3, the IBDQ score improved by the antibiotic therapy continued to be high throughout the one-year follow-up, while the improved IBDQ score in the 15 patients who relapsed on placebo deteriorated significantly at the time of relapse. CONCLUSION: VSL#3 is extremely effective in maintaining remission and improved QOL in patients with previous recurrent or refractory chronic pouchitis (which had been healed byantibiotics). The once daily dose is effective.
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