rct
    2024
    High Quality

    A randomized double-blind, placebo-controlled trial to evaluate the safety and efficacy of live Bifidobacterium longum CECT 7347 (ES1) and heat-treated Bifidobacterium longum CECT 7347 (HT-ES1) in participants with diarrhea-predominant irritable bowel syndrome

    Srivastava S, Basak U, Naghibi M, Vijayakumar V, Parihar R

    Published in Gut Microbes

    Methodology

    Randomised, double-blind, placebo-controlled three-arm trial in 200 adults with IBS-D receiving live ES1, heat-treated HT-ES1 or placebo daily for 84 days, with IBS-SSS as the primary outcome.

    Key Findings

    Mean IBS-SSS fell by -173.70 with ES1 and -177.60 with HT-ES1 versus -60.44 with placebo (both p<0.0001), with significant improvements in quality of life, abdominal pain, stool consistency and anxiety scores.

    Conclusions

    Both live and heat-treated B. longum CECT 7347 reduced IBS-D symptom severity compared with placebo.

    Limitations

    Single manufacturer-sponsored trial in one population; IBS-D only; large placebo-controlled effect not yet independently replicated.

    Supplements Studied

    The decrease in mean IBS-SSS score from baseline to Day 84 was: ES1 (-173.70) vs placebo (-60.44) (p < .0001).

    Outcomes Measured

    Secondary outcomes included changes in IBS-QoL, APS-NRS, stool consistency and STAI-S and STAI-T scores, with changes from baseline to Day 84 being significant in ES1 and HT-ES1 groups.

    Related Health Concerns

    Study Details

    Year:2024
    Sample Size:200
    Duration:12 weeks
    Quality Score:8/10

    Disclosures

    Funding

    Industry (probiotic manufacturer) funded

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