Published online Jun 14, 2022. doi: 10.3748/wjg.v28.i22.2509
Peer-review started: December 22, 2021
First decision: January 8, 2022
Revised: January 14, 2022
Accepted: April 28, 2022
Article in press: April 28, 2022
Published online: June 14, 2022
Probiotics are a promising solution for managing irritable bowel syndrome (IBS). Saccharomyces cerevisiae (S. cerevisiae) I-3856 has already demonstrated beneficial effects in IBS subjects, particularly in IBS with predominant constipation (IBS-C).
To confirm the efficacy of S. cerevisiae I-3856 in the management of gastrointestinal symptoms in IBS-C.
A randomized, double-blind, placebo-controlled clinical study was performed in a total of 456 subjects. After a run-in period, subjects were randomly assigned to the group receiving S. cerevisiae I-3856 (8 × 109 CFU daily) or the placebo for 8 wk, and they performed daily self-evaluations of gastrointestinal symptoms. The primary objective was to assess the effect of the probiotic on abdominal pain. The secondary objectives were the evaluation of other gastrointestinal symptoms, bowel movement frequency and consistency, and quality of life (QOL).
A significantly higher proportion of abdominal pain responders was reported in the Probiotic group (45.1% vs 33.9%, P = 0.017). A nonsignificant difference in the area under the curve for abdominal pain over the second month of supplementation was observed in subjects receiving probiotic vs placebo [P = 0.073, 95%CI: -0.59 (-1.23; 0.05)]. No statistically significant differences were reported in the evolution of bowel movement frequency and stool consistency between the groups. After 8 wk of supplementation, the overall QOL score was significantly higher in the Probiotic group than in the Placebo group [P = 0.047, 95%CI: 3.86 (0.52; 7.20)]. Furthermore, exploratory analyses showed statistically significant and clinically relevant improvements in QOL scores in abdominal pain responders vs nonresponders.
The results of this clinical study confirmed the abdominal pain alleviation properties of S. cerevisiae I-3856 in IBS-C. Abdominal pain relief was associated with improved QOL. ClinicalTrials.gov identifier: NCT03150212.
Core Tip: The gut microbiota has been proposed as central in irritable bowel syndrome (IBS) pathophysiology, and microbiota-directed intervention has therefore drawn considerable interest. Probiotics have been recognized as a potential solution for acting on the multifactorial causes and clinical symptoms of IBS. Among them, Saccharomyces cerevisiae (S. cerevisiae) CNCM I-3856 is a probiotic yeast that has shown beneficial effects on gastrointestinal symptoms of individuals with IBS, especially in IBS subjects with predominant constipation. This clinical study confirmed the abdominal pain alleviation properties of S. cerevisiae I-3856 in IBS with predominant constipation and showed improvements in quality of life in the group receiving the probiotic.