A randomized placebo-controlled clinical trial of a multi-strain probiotic formulation (Bio-Kult®) in the management of diarrhea-predominant irritable bowel syndrome

Shamsuddin M Ishaque, S M Khosruzzaman, Dewan Saifuddin Ahmed, Mukesh Prasad Sah, Shamsuddin M Ishaque, S M Khosruzzaman, Dewan Saifuddin Ahmed, Mukesh Prasad Sah

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].

Keywords: BioKult; Diarrhea; Gastrointestinal well-being; IBS; Multi-strain probiotic; Probiotic; Quality of life; Randomized controlled trial.

Conflict of interest statement

Ethics approval and consent to participate

Ethical approval was obtained from IRB (Institutional Review Board) BSMMU, Dhaka prior to commencement of the study; reference number BSMMU/2015/1011. Informed consent to participate in the study was obtained from all participants. All participants were informed about the objectives, methodology, and purpose of the study in an easily understandable way, and those who agreed to participate were required to provide verbal and written consent prior to entry.

Consent for publication

Verbal and written consent for publication was obtained from participate.

Competing interests

All authors declare that:

1. They have no non-financial interest that may be relevant to the submitted work.

2. All authors confirm no other relationship with Probiotics International Ltd. (Protexin) whose.

involvement in the study was confined to supply of Bio-Kult® probiotic and placebo capsules, review.

of the draft manuscript and financial support for medical writing.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Study protocol
Fig. 2
Fig. 2
IBS-SSS abdominal pain ratings with probiotic (Bio-Kult®) or placebo (16 weeks’ treatment and 1-month follow-up). The lower the score the less the pain: * p = 0.002; ** p < 0.001; NS = not significant
Fig. 3
Fig. 3
Individual dimension scores for IBS-QoL during 16 weeks’ treatment with multi-strain probiotic (Bio-Kult®; blue square) or placebo (red square). * p < 0.05; ** p < 0.001; NS, not significant. Note: In this scoring system, higher scores indicate better QoL

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