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

May 20, 2019 updated by: Lesaffre International

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
456

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 71 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Abdominal pain/discomfort score rated with Likert scale (ranging from 0 to 7)
Time Frame: Week 5 to Week 8
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lesaffre International

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 20, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 9, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 9, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 21, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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