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

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 IBSD 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].

Management of irritable bowel syndrome with diarrhea: a review of nonpharmacological and pharmacological interventions

“…30 Further, a significantly greater percentage of patients receiving probiotics were symptom-free compared with placebo after 16 weeks (33.7% versus 12.8%, respectively; p < 0.001). 30 The European Society for Primary Care Gastroenterology has recommended use of probiotics for improvement of global IBS symptoms in some patients, based on findings of a meta-analysis of 23 studies (n = 3112 patients with IBS) that included 19 different probiotics (high grade of evidence). 31 A similar recommendation was made for probiotic use in patients with IBS-D specifically, based on data from seven studies (n = 495 patients with IBS-D; low grade of evidence).…”

“…28 A secondary analysis of a double-blind RCT of patients with IBS-D receiving a combination probiotic product (i.e. 30 Further, a significantly greater percentage of patients receiving probiotics were symptom-free compared with placebo after 16 weeks (33.7% versus 12.8%, respectively; p < 0.001). 30 The European Society for Primary Care Gastroenterology has recommended use of probiotics for improvement of global IBS symptoms in some patients, based on findings of a meta-analysis of 23 studies (n = 3112 patients with IBS) that included 19 different probiotics (high grade of evidence).…”

Comparing probiotic and drug interventions in irritable bowel syndrome: a meta-analysis of randomised controlled trials

“…We first analysed pooled data from studies utilising persistence of IBS symptoms as a dichotomous variable. 11 RCTs compared probiotics with placebo for the treatment of persistence of IBS symptoms (responder vs non-responders), evaluating 2,365 patients (Andresen et al, 2020;De Chambrun et al, 2015;Hod et al, 2017;Ishaque et al, 2018;Lyra et al, 2016;Martoni et al, 2020;Mezzasalma et al, 2016;Oh et al, 2019;Sun et al, 2018;Thijssen et al, 2016). Compared to placebo, the experimental group was associated with a significantly lower persistence of IBS symptoms (RR=0.68; 95% CI 0.51; 0.92) with a significant degree of heterogeneity between studies (I 2 =82%, P<0.01; Figure 2).…”

“…Pooled data from studies utilising the effect of probiotics on global IBS symptoms or abdominal pain scores were analysed as a continuous variable. 10 RCTs compared probiotics with placebo for the treatment of abdominal pain, evaluating 1,999 patients (Bonfrate et al, 2020;De Chambrun et al, 2015;Faghihi et al, 2015;Ishaque et al, 2018;Lyra et al, 2016;Martoni et al, 2020;Preston et al, 2018;Sun et al, 2018;Thijssen et al, 2016). Compared to placebo, the experimental group was associated with significantly lower abdominal pain scores (standardised mean difference (SMD) -0.35; 95% CI -0.56; -0.14) with a significant degree of heterogeneity between studies (I 2 =77%, P<0.01; Figure 3).…”

An insight into the functional alterations in the gut microbiome of healthy adults in response to a multi-strain probiotic intake: a single arm open label trial

“…The effectiveness of the 14 strain probiotic blend has been assessed in several randomized, placebo-controlled trials (RCTs). The 14 strain blend was reported to be safe and efficacious, improving various aspects of GI distress over a period of 4 months in irritable bowel syndrome (IBS) diarrhea-predominant subjects (Ishaque et al, 2018). Furthermore, the multi-strain probiotic significantly reduced the frequency and severity of migraines in subjects experiencing episodic and chronic migraines (Martami et al, 2019) and significantly improved depression scores in individuals with low mood (Baião et al, 2022).…”