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Randomized double blind placebo-controlled trial of Saccharomyces cerevisiae CNCM I-3856 in irritable bowel syndrome: improvement in abdominal pain and bloating in those with predominant constipation.
United European Gastroenterol J. 2016 Jun; 4(3):353-62.UE

Abstract

BACKGROUND

Irritable bowel syndrome (IBS) is a common functional gastrointestinal disorder characterized by recurrent abdominal pain and/or discomfort. Probiotics have been reported to benefit IBS symptoms but the level of benefit remains quite unclear.

OBJECTIVE

This study was designed to assess the benefit of Saccharomyces cerevisiae I-3856 on IBS symptoms.

METHODS

A randomized, double blind, placebo-controlled trial has been performed in 379 subjects with diagnosed IBS. Subjects were randomly supplemented with the probiotics (1000 mg) or placebo for 12 weeks. Questionnaires (gastrointestinal symptoms, stools, wellbeing, and quality of life) were completed. Primary endpoint was percentage of responders defined as having a 50% decrease in the weekly average "intestinal pain/discomfort score" for at least 4 out of the last 8 weeks of the study.

RESULTS

There was no overall benefit of S. cerevisiae I-3856 on IBS symptoms and wellbeing in the study population. Moreover, S. cerevisiae I-3856 was not statistically significant predictor of the responder status of the subjects (p > 0.05). Planned subgroup analyses showed significant effect in the IBS-C subjects: improvement of gastrointestinal symptoms was significantly higher in active group, compared to placebo, on abdominal pain/discomfort and bloating throughout the study and at the end of the supplementation.

CONCLUSIONS

In this study, S. cerevisiae I-3856 at the dose of 1000 mg per day does not improve intestinal pain and discomfort in general IBS patients. However, it seems to have an effect in the subgroup with constipation which needs further studies to confirm (NCT01613456 in ClinicalTrials.gov registry).

Authors+Show Affiliations

Nottingham Digestive Diseases Biomedical Research Unit, Nottingham Digestive Diseases Centre, Nottingham, United Kingdom.Lesaffre Human Care, Lesaffre Group, Marcq en Baroeul, France.Lesaffre Human Care, Lesaffre Group, Marcq en Baroeul, France.Biofortis-Mérieux NutriSciences, Saint-Herblain, France.Biofortis-Mérieux NutriSciences, Saint-Herblain, France.Biofortis-Mérieux NutriSciences, Saint-Herblain, France.Lesaffre Human Care, Lesaffre Group, Marcq en Baroeul, France.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

27403301

Citation

Spiller, Robin, et al. "Randomized Double Blind Placebo-controlled Trial of Saccharomyces Cerevisiae CNCM I-3856 in Irritable Bowel Syndrome: Improvement in Abdominal Pain and Bloating in Those With Predominant Constipation." United European Gastroenterology Journal, vol. 4, no. 3, 2016, pp. 353-62.
Spiller R, Pélerin F, Cayzeele Decherf A, et al. Randomized double blind placebo-controlled trial of Saccharomyces cerevisiae CNCM I-3856 in irritable bowel syndrome: improvement in abdominal pain and bloating in those with predominant constipation. United European Gastroenterol J. 2016;4(3):353-62.
Spiller, R., Pélerin, F., Cayzeele Decherf, A., Maudet, C., Housez, B., Cazaubiel, M., & Jüsten, P. (2016). Randomized double blind placebo-controlled trial of Saccharomyces cerevisiae CNCM I-3856 in irritable bowel syndrome: improvement in abdominal pain and bloating in those with predominant constipation. United European Gastroenterology Journal, 4(3), 353-62. https://doi.org/10.1177/2050640615602571
Spiller R, et al. Randomized Double Blind Placebo-controlled Trial of Saccharomyces Cerevisiae CNCM I-3856 in Irritable Bowel Syndrome: Improvement in Abdominal Pain and Bloating in Those With Predominant Constipation. United European Gastroenterol J. 2016;4(3):353-62. PubMed PMID: 27403301.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomized double blind placebo-controlled trial of Saccharomyces cerevisiae CNCM I-3856 in irritable bowel syndrome: improvement in abdominal pain and bloating in those with predominant constipation. AU - Spiller,Robin, AU - Pélerin,Fanny, AU - Cayzeele Decherf,Amélie, AU - Maudet,Corinne, AU - Housez,Béatrice, AU - Cazaubiel,Murielle, AU - Jüsten,Peter, Y1 - 2015/08/21/ PY - 2015/03/20/received PY - 2015/07/28/accepted PY - 2016/7/13/entrez PY - 2016/7/13/pubmed PY - 2016/7/13/medline KW - Irritable bowel syndrome KW - abdominal pain KW - constipation KW - probiotics KW - yeast SP - 353 EP - 62 JF - United European gastroenterology journal JO - United European Gastroenterol J VL - 4 IS - 3 N2 - BACKGROUND: Irritable bowel syndrome (IBS) is a common functional gastrointestinal disorder characterized by recurrent abdominal pain and/or discomfort. Probiotics have been reported to benefit IBS symptoms but the level of benefit remains quite unclear. OBJECTIVE: This study was designed to assess the benefit of Saccharomyces cerevisiae I-3856 on IBS symptoms. METHODS: A randomized, double blind, placebo-controlled trial has been performed in 379 subjects with diagnosed IBS. Subjects were randomly supplemented with the probiotics (1000 mg) or placebo for 12 weeks. Questionnaires (gastrointestinal symptoms, stools, wellbeing, and quality of life) were completed. Primary endpoint was percentage of responders defined as having a 50% decrease in the weekly average "intestinal pain/discomfort score" for at least 4 out of the last 8 weeks of the study. RESULTS: There was no overall benefit of S. cerevisiae I-3856 on IBS symptoms and wellbeing in the study population. Moreover, S. cerevisiae I-3856 was not statistically significant predictor of the responder status of the subjects (p > 0.05). Planned subgroup analyses showed significant effect in the IBS-C subjects: improvement of gastrointestinal symptoms was significantly higher in active group, compared to placebo, on abdominal pain/discomfort and bloating throughout the study and at the end of the supplementation. CONCLUSIONS: In this study, S. cerevisiae I-3856 at the dose of 1000 mg per day does not improve intestinal pain and discomfort in general IBS patients. However, it seems to have an effect in the subgroup with constipation which needs further studies to confirm (NCT01613456 in ClinicalTrials.gov registry). SN - 2050-6406 UR - https://www.unboundmedicine.com/medline/citation/27403301/Randomized_double_blind_placebo_controlled_trial_of_Saccharomyces_cerevisiae_CNCM_I_3856_in_irritable_bowel_syndrome:_improvement_in_abdominal_pain_and_bloating_in_those_with_predominant_constipation_ L2 - https://journals.sagepub.com/doi/10.1177/2050640615602571?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -