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.
השאירו תגובה
רוצה להצטרף לדיון?תרגישו חופשי לתרום!