Effect of Saccharomyces Cerevisiae on the Improvement of Gastro-intestinal Disorders Associated to IBS With C Phenotype (IBS-GO)

Randomized Double Blind Placebo-controlled Clinical Study : Effect of IBSIUM on the Improvement of Gastro-intestinal Disorders Associated to the Irritable Bowel Syndrome (IBS) With C Phenotype (Predominant-constipation)

The main objective is to assess the effect of an 8-week daily supplementation with IbSium® (probiotic yeast Saccharomyces cerevisiae CNCM I-3856) on the improvement gastro-intestinal disorders associated to the type C IBS (constipation predominant).

Study Overview

• Status: Completed
• Conditions: Constipation-predominant Irritable Bowel Syndrome
• Intervention / Treatment: Dietary supplement: Saccharomyces cerevisiae CNCM I-3856; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 456
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • France, France
    • General pratices
  • Gieres, France
    • Eurofins Optimed
  • Givors, France
    • Créabio Rhône Alpes
  • Lille, France
    • Institut Pasteur de Lille
  • Saint Herblain, France, 44800
    • Biofortis Mérieux NutriSciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Presenting IBS with predominant constipation according to the Rome IV criteria from at least 1 year and less than 10 years and without any possible doubt concerning confounding organic lesions (other organic pathologies having been excluded compliantly to the usual recommendations using differential diagnostic of chronic abdominal pain)

Rome IV:

A) Recurrent abdominal pain, with an average of at least 1 day a week within the last 3 months, and associated with 2 following criteria:

1. Related to defecation,
2. Associated with a change in stool frequency,
3. Associated with a change of the stools appearance.

B) Onset of the above symptoms at least 6 months before the diagnostic,

C) More than one-fourth (25%) of bowel movements with Bristol stool form types 1 or 2 and less than one-fourth (25%) of bowel movements with Bristol stool form types 6 or 7 (check during the last 14 days using the stools frequency questionnaire associated to the Bristol Stools Scale "BSS"),

• Score of abdominal pain/discomfort ≥ 2 and < 6 (using a 0 to 7 Likert point scale; daily average during the last 14 days verified at V1),
• For non-menopausal women: with the same efficient contraception method since at least 3 months before the start of the study, and accepting to maintain this program over the study (hormonal contraception, intrauterine device or surgical intervention). For menopausal women: with or without Hormone Replacement Therapy (HRT in place since less than 3 months before the start of the study are excluded) ,

Exclusion Criteria:

• Suffering from gastro-intestinal troubles other than IBS: lactose intolerance, Crohn disease, ulcerative colitis, celiac disease (gluten intolerance), symptomatic diverticulosis,
• Suffering from an immunodeficiency or affected by a severe or progressive disease (cardiac, pukmonary, hepatic, renal, hematologic, infectious or neoplastic),
• Suffering from a metabolic trouble affecting the intestinal transit function or the nutrients absorption like diabetes or unbalanced thyroid dysfunction,
• Currently under symptomatic drug treatment acting on the intestinal sensitivity or motility (laxatives, antispasmodics, anxiolytics, antidepressants, analgesics and NSAIDs are authorized if consumed for more than 3 months with a stable dosage and maintained during the study; opioïds and narcotic analgesics are forbidden), or dietary supplementation which according to the investigator should affect study results or stopped within a too short time window before the V1 randomization visit (less than 4 weeks for oral antibiotics, pre- or probiotics, less than 2 weeks for oral antifungal and anti-diarrheal if gastroenteritis),
• Refusing to stop the consumption of probiotics, prebiotics, or symbiotics under dietary supplement presentation or "health foods" (i.e. Lactibiane®, BION®, ultra yeast, kefir or food stuffs like ACTIMEL®, ACTIVIA® or other probiotics enriched dairy product etc.),
• Pregnant or lactating woman or intenting to become pregnant within 3 months ahead,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; 2 capsules daily, just before the breakfast with a glass of water, during 8 weeks.
Experimental: Saccharomyces cerevisiae CNCM I-3856	Dietary supplement: Saccharomyces cerevisiae CNCM I-3856; 2 capsules daily, just before the breakfast with a glass of water, during 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abdominal pain/discomfort score rated with Likert scale (ranging from 0 to 7)	Total AUC W5-W8 (expressed in a.u./day.week) of abdominal pain/discomfort calculated using the mean daily score rated with Likert scale (ranging from 0 to 7) from week 5 to week 8 (included)	Week 5 to Week 8

Collaborators and Investigators

• Sponsor: Lesaffre International
• Investigators: Principal Investigator: Isabelle METREAU, MD, Biofortis Mérieux NutriSciences; Principal Investigator: Arnaud BOURREILLE, Doctor, Service d'Hépatogastroentérologie - CHU Nantes; Principal Investigator: Pierre DESREUMAUX, Professor, Service de Gastroentérologie - Hôpital Huriez, CHU Lille

Publications and helpful links

General Publications

• Mourey F, Decherf A, Jeanne JF, Clement-Ziza M, Grisoni ML, Machuron F, Legrain-Raspaud S, Bourreille A, Desreumaux P. Saccharomyces cerevisiae I-3856 in irritable bowel syndrome with predominant constipation. World J Gastroenterol. 2022 Jun 14;28(22):2509-2522. doi: 10.3748/wjg.v28.i22.2509.

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2017
• Primary Completion (Actual): May 9, 2019
• Study Completion (Actual): May 9, 2019

Study Registration Dates

• First Submitted: May 10, 2017
• First Submitted That Met QC Criteria: May 10, 2017
• First Posted (Actual): May 12, 2017

Study Record Updates

• Last Update Posted (Actual): May 21, 2019
• Last Update Submitted That Met QC Criteria: May 20, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Signs and Symptoms, Digestive; Colonic Diseases, Functional; Colonic Diseases; Syndrome; Irritable Bowel Syndrome; Gastrointestinal Diseases; Digestive System Diseases; Constipation; Intestinal Diseases
• Other Study ID Numbers: 2016-A01574-47

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No