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Randomized Controlled Trial
. 2022 Jun 14;28(22):2509-2522.
doi: 10.3748/wjg.v28.i22.2509.

Saccharomyces cerevisiae I-3856 in irritable bowel syndrome with predominant constipation

Florian Mourey  1 , Amélie Decherf  2 , Jean-François Jeanne  2 , Mathieu Clément-Ziza  3 , Marie-Lise Grisoni  3 , François Machuron  3 , Sophie Legrain-Raspaud  2 , Arnaud Bourreille  4 , Pierre Desreumaux  5
Affiliations
Randomized Controlled Trial

Saccharomyces cerevisiae I-3856 in irritable bowel syndrome with predominant constipation

Florian Mourey et al. World J Gastroenterol. .

Abstract

Background: 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).

Aim: To confirm the efficacy of S. cerevisiae I-3856 in the management of gastrointestinal symptoms in IBS-C.

Methods: 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).

Results: 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.

Conclusion: 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.

Keywords: Abdominal pain; Irritable bowel syndrome; Probiotic; Quality of life; Saccharomyces cerevisiae; Yeast.

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Conflict of interest statement

Conflict-of-interest statement: Mourey F, Decherf A, Jeanne JF, Clément-Ziza M, Machuron F and Legrain-Raspaud S are employees of Lesaffre. Grisoni ML was an employee of Lesaffre during her main contribution to the study. Bourreille A and Desreumaux P received financial support for research from Lesaffre.

Figures

Figure 1
Figure 1
Study design.
Figure 2
Figure 2
CONSORT flow diagram.
Figure 3
Figure 3
Abdominal pain. A: Abdominal pain score evolution; B: Area under the curve (W5-W8) of abdominal pain; C: Percentage of abdominal pain responders in the ITT population. Significant result (aP < 0.05, Chi2 test). Similar profiles were obtained for the PP population (Supplementary Figure 1).
Figure 4
Figure 4
Irritable bowel syndrome-specific quality of life questionnaire scores at the end of the intervention (V3) in the PP population. Significant result (aP < 0.05, ANOVA model).
Figure 5
Figure 5
Irritable bowel syndrome-specific quality of life questionnaire scores at the end of the intervention (V3) adjusted to baseline (V1) in ITT abdominal pain responders supplemented with Saccharomyces cerevisiae CNCM I-3856. PP population radar plot: Supplementary Figure 3. Significant result (aP < 0.05, ANCOVA for repeated measures). Between-group differences are shown in Supplementary Table 2.
See this image and copyright information in PMC

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