Randomised clinical trial: a liquid multi‐strain probiotic vs. placebo in the irritable bowel syndrome – a 12 week double‐blind study. Issue 1 (11th May 2014)

• Record Type: Journal Article
• Authors: Sisson, G.; Ayis, S.; Sherwood, R. A.; Bjarnason, I.
• Is Part Of: Alimentary pharmacology & therapeutics. Volume 40:Issue 1(2014)
• Page Start: 51
• Page End: 62
• Publication Date: 2014-05-11
• Subjects: Digestive organs -- Diseases -- Treatment -- Periodicals; Digestive organs -- Effect of drugs on -- Periodicals; Gastrointestinal system -- Diseases -- Treatment -- Periodicals; Gastrointestinal system -- Effect of drugs on -- Periodicals; 615.73
• DOI: 10.1111/apt.12787
• Languages: English
• ISSNs: 0269-2813

Abstract

<abstract abstract-type="main" id="apt12787-abs-0001"> <title>Summary</title> <sec id="apt12787-sec-0001" sec-type="section"> <title>Background</title> <p>The importance of interactions between the host and gut microbiota in the pathogenesis of irritable bowel syndrome (IBS) is becoming increasingly apparent. Probiotics offer a potential new treatment for IBS, but current results are conflicting, largely as a result of poorly designed trials and nonstandardisation of outcome measures.</p> </sec> <sec id="apt12787-sec-0002" sec-type="section"> <title>Aim</title> <p>To assess the efficacy of a liquid, multi‐strain probiotic (Symprove) in IBS.</p> </sec> <sec id="apt12787-sec-0003" sec-type="section"> <title>Methods</title> <p>A single‐centre, randomised, double‐blind, placebo‐controlled trial of adult patients with symptomatic IBS. Patients received 12 weeks of treatment with the probiotic or placebo (1 mL/kg/day). The primary efficacy measure was the difference in change in the IBS symptom severity score (IBS‐SSS) between probiotic vs. placebo at week 12. Secondary outcome measures included change in the IBS quality of life (IBS‐QOL) score and change in the IBS‐SSS symptom component scores.</p> </sec> <sec id="apt12787-sec-0004" sec-type="section"> <title>Results</title> <p>A total of 186 patients were randomised and 152 patients completed the study. The mean change in IBS‐SSS was −63.3 probiotic vs. −28.3 placebo. The mean difference in the IBS‐SSS was statistically significant [−35.0 (95% CI; −62.03, −7.87); <italic>P</italic> = 0.01]. There was no significant improvement in the IBS‐QOL. No serious adverse events were reported.</p> </sec> <sec id="apt12787-sec-0005" sec-type="section"> <title>Conclusions</title> <p>The multi‐strain probiotic was associated with a statistically significant improvement in overall symptom severity in patients with IBS, and was well tolerated. These results suggest this probiotic confers benefit in IBS and deserves further investigation (ISRCTN identifier: 77512412).</p> </sec> </abstract>