Plain language summary
Irritable bowel syndrome (IBS) is a common condition that has varied symptoms and affects an individual’s quality of life. Whilst there is no one clear factor known to cause IBS, growing evidence suggests that an imbalance of gut bacteria may contribute to IBS symptoms. In this randomised, double-blinded, placebo controlled trial, 400 patients with diarrhea-predominant IBS were assigned to 16 weeks of a multi-strain probiotic, Bio-Kult, or a placebo. Changes to the severity and frequency of abdominal pain, frequency and consistency of bowel movements and quality of life scores were monitored at intervals during the trial period and one month post-treatment. The treatment group receiving the probiotic therapy reported a 69% reduction in abdominal pain (placebo reported a 47% reduction). The number of bowel movements from month 2 of treatment was also significantly improved for the treatment group, as well as all dimensions of quality of life. This study was funded by Protexin, the manufacturers of Bio-Kult Probiotics.
Abstract
BACKGROUND Accumulating evidence supports the view that an imbalance of gut bacteria contributes to IBS, and that increasing the mass of beneficial species may reduce the numbers of pathogenic bacteria and help alleviate symptoms. METHODS In this double-blind trial 400 adult patients with moderate-to-severe symptomatic diarrhea-predominant IBS (IBS-D) were randomized to treatment with the multi-strain probiotic Bio-Kult® (14 different bacterial strains) or placebo for 16 weeks. The change in severity and frequency of abdominal pain was the primary outcome measure. RESULTS Probiotic treatment significantly improved the severity of abdominal pain in patients with IBS-D. A 69% reduction for probiotic versus 47% for placebo (p < 0.001) equates to a 145 point reduction on the IBS-severity scoring system (IBS-SSS). The proportion of patients who rated their symptoms as moderate-to-severe was reduced from 100% at baseline to 14% for the multi-strain probiotic at follow-up (month 5) versus 48% for placebo (p < 0.001). Also, the number of bowel motions per day from month 2 onwards was significantly reduced in the probiotic group compared with the placebo group (p < 0.05). In addition to relieving symptoms, the probiotic markedly improved all dimensions of quality of life in the 34-item IBS-Quality of Life (IBS-QoL) questionnaire. No serious adverse events were reported. CONCLUSIONS The multi-strain probiotic was associated with significant improvement in symptoms in patients with IBS-D and was well-tolerated. These results suggest that probiotics confer a benefit in IBS-D patients which deserves further investigation. TRIAL REGISTRATION [Clinicaltrials.gov NCT03251625 ; retrospectively registered on August 9, 2017].
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