A randomized double-blind, placebo-controlled trial to evaluate the safety and efficacy of live <i>Bifidobacterium longum</i> CECT 7347 (ES1) and heat-treated <i>Bifidobacterium longum</i> CECT 7347 (HT-ES1) in participants with diarrhea-predominant irritable bowel syndrome
Shalini Srivastava, Ustaalioglu Oven Basak, M. Naghibi, Vineetha Vijayakumar, Ripu Daman Parihar, Jay Patel, PS Jadon, Anuja Pandit, RR Dargad, Shweta Khanna, Sachin Kumar, Richard O. Day
Abstract
To determine the efficacy of the probiotic Bifidobacterium longum CECT 7347 (ES1) and postbiotic heat-treated Bifidobacterium longum CECT 7347 (HT-ES1) in improving symptom severity in adults with diarrhea-predominant irritable bowel syndrome (IBS-D), a randomised, double-blind, placebo-controlled trial with 200 participants split into three groups was carried out. Two capsules of either ES1, HT-ES1 or placebo were administered orally, once daily, for 84 days (12 weeks). The primary outcome was change in total IBS-Symptom Severity Scale (IBS-SSS) score from baseline, compared to placebo. Secondary outcome measures were stool consistency, quality of life, abdominal pain severity and anxiety scores. Safety parameters and adverse events were also monitored. The change in IBS-SSS scores from baseline compared to placebo, reached significance in the ES1 and HT-ES1 group, on Days 28, 56 and 84. The decrease in mean IBS-SSS score from baseline to Day 84 was: ES1 (−173.70 [±75.60]) vs placebo (−60.44 [±65.5]) (p < .0001) and HT-ES1 (−177.60 [±79.32]) vs placebo (−60.44 [±65.5]) (p < .0001). 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, compared to the placebo group. Both ES1 and HT-ES1 were effective in reducing IBS-D symptom severity, as evaluated by measures such as IBS-SSS, IBS-QoL, APS-NRS, stool consistency, and STAI, in comparison to the placebo. These results are both statistically significant and clinically meaningful, representing, to the best of the authors’ knowledge, the first positive results observed for either a probiotic or postbiotic from the same strain, in this particular population.