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

Abstract

BackgroundAccumulating 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.MethodsIn 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.ResultsProbiotic 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.ConclusionsThe 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].Electronic supplementary materialThe online version of this article (doi:10.1186/s12876-018-0788-9) contains supplementary material, which is available to authorized users.

Efficacy and Safety of Probiotics, Prebiotics and Synbiotics in the Treatment of Irritable Bowel Syndrome: A systematic review and meta-analysis

“…Overall, there were a total of 4,321 patients with IBS, of which 59.5% were female. In terms of IBS subtypes, six RCTs included patients with IBS-D, one with IBS-C and one with both IBS-D and IBS-M. [26][27][28][29][30][31][32][33] The remaining trials included patients with all subtypes. With regards to location, the majority of the trials were conducted in Europe (n = 18) followed by Asia (n = 13).…”

“…With regards to location, the majority of the trials were conducted in Europe (n = 18) followed by Asia (n = 13). [26][27][28][29][30][31][32][33] The remaining two RCTs were based in South Africa and the USA, respectively. 34,35 The Rome I criteria were used for diagnosis in two trials, while the Rome II criteria were used in 11 trials.…”

“…[32][33][34][40][41][42][43][44][45][46][47][48][49] The rest of the trials utilised the Rome III criteria. [26][27][28][29][30][31][35][36][37][38][39][50][51][52][53][54][55][56][57][58] In terms of intervention, three trials investigated prebiotics (partially-hydrolysed guar gum and fructooligosaccharides) and three investigated synbiotics. 38,40,42,50,51 The remaining 27 RCTs evaluated probiotics.…”

“…[26][27][28][29][30][31][32][33][34][35][36][37]39,41,43,44,[46][47][48][49][52][53][54][55][56][57][58] Just over half of the probiotic trials contained multiple bacterial strains (n = 14). [29][30][31][32]35,37,44,[47][48][49][52][53][54] The other 13 trials contained single strains, comprising of Lactobacillus, Bifi- dobacterium and Saccharomyces species as well as Clostridium butyricum. [26][27][28]33,34,36,39,41,43,[55]…”

“…39 The remaining trials employed a double-blinded design. [26][27][28][29][30][31][32][33][34][35][36][37][38][40][41][42][43][44][45][46][47][48][49][50][51][52][53][54][55][56][57][58] The method of randomisation was not explicitly mentioned in five trials (15.2%); this was therefore categorised as an unclear risk in the risk of bias assessment under the random sequence generation domain. 32,35,41,43,46 Block randomisation and a random allocation table was used in 12 RCTs each.…”