A randomized controlled trial of a probiotic combination VSL# 3 and placebo in irritable bowel syndrome with bloating

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Abstract
Aim: To evaluate the effects of a combination probiotic on symptoms and colonic transit in patients with irritable bowel syndrome (IBS) and significant bloating. Methods: Forty‐eight patients with Rome II IBS were randomized in a parallel group, double‐blind design to placebo or VSL# 3 twice daily (31 patients received 4 weeks and 17 patients 8 weeks of treatment). Pre‐ and post‐treatment colonic transit measurements were performed using scintigraphy with 111In charcoal. Symptoms were summarized as an average daily score for the entire period of treatment and separately for the first 4 weeks of treatment. Weekly satisfactory relief of abdominal bloating was assessed. Results: Treatment with VSL# 3 was associated with reduced flatulence over the entire treatment period (placebo 39.5 ± 2.6 vs VSL# 3 29.7 ± 2.6, P = 0.011); similarly, during the first 4 weeks of treatment, flatulence scores were reduced (placebo 40.1 ± 2.5 vs VSL# 3 30.8 ± 2.5, P = 0.014). Proportions of responders for satisfactory relief of bloating, stool‐related symptoms, abdominal pain and bloating scores were not different. Colonic transit was retarded with VSL# 3 relative to placebo (colon geometric center 2.27 ± 0.20 vs 2.83 ± 0.19, P = 0.05 respectively). Conclusion: VSL# 3 reduces flatulence scores and retards colonic transit without altering bowel function in patients with IBS and bloating.

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