Constipation-predominant Irritable Bowel SyndromeIBS-GONCT03150212
Effect of Saccharomyces Cerevisiae on the Improvement of Gastro-intestinal Disorders Associated to IBS With C Phenotype
A study testing Saccharomyces cerevisiae CNCM I-3856 in people with Constipation-predominant Irritable Bowel Syndrome, run by Lesaffre International at 5 sites in France.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Constipation-predominant Irritable Bowel Syndrome
- What is being tested?
- Saccharomyces cerevisiae CNCM I-3856
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 456 participants
- Where
- 5 sitesFrance
- Study dates
- 20 Mar 2017to 9 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
- Recurrent abdominal pain, with an average of at least 1 day a week within the last 3 months, and associated with 2 following criteria:
- Related to defecation,
- Associated with a change in stool frequency,
- Associated with a change of the stools appearance.
Show all 10Show fewer
- Onset of the above symptoms at least 6 months before the diagnostic,
- 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) ,
Who cannot join
- 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,
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
General pratices
France
Eurofins Optimed
Gières
Créabio Rhône Alpes
Givors
Institut Pasteur de Lille
Lille
Biofortis Mérieux NutriSciences
Saint-Herblain, 44800
About this study
Official title: 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).
- Being tested
- Saccharomyces cerevisiae CNCM I-3856, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saccharomyces cerevisiae CNCM I-3856Dietary supplement
2 capsules daily, just before the breakfast with a glass of water, during 8 weeks.
PlaceboDietary supplement
2 capsules daily, just before the breakfast with a glass of water, during 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Saccharomyces cerevisiae CNCM I-3856 | Experimental | Not described Receives: Dietary Supplement: Saccharomyces cerevisiae CNCM I-3856 |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Week 5 to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start20 Mar 2017
- Primary completion9 May 2019
- Study completion9 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Constipation-predominant Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 456 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lesaffre International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Isabelle METREAU, MD, Principal investigator, Biofortis Mérieux NutriSciencesArnaud BOURREILLE, Doctor, Principal investigator, Service d'Hépatogastroentérologie - CHU NantesPierre DESREUMAUX, Professor, Principal investigator, Service de Gastroentérologie - Hôpital Huriez, CHU Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03150212
- Sponsor's protocol ID
- 2016-A01574-47
- Acronym
- IBS-GO
- Status last verified
- May 2019
- First submitted
- 10 May 2017
- Last updated
- 21 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35979259
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT03150212
- Acronym / sponsor ID
- IBS-GO / 2016-A01574-47
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 456 participants (actual)
- Lead sponsor
- Lesaffre InternationalIndustry (pharma, biotech, devices)
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 9 May 2019 (actual)
- Study completion
- 9 May 2019 (actual)
- First posted
- 12 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saccharomyces cerevisiae CNCM I-3856 | Experimental | Dietary Supplement: Saccharomyces cerevisiae CNCM I-3856 |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
- Recurrent abdominal pain, with an average of at least 1 day a week within the last 3 months, and associated with 2 following criteria:
- Related to defecation,
- Associated with a change in stool frequency,
- Associated with a change of the stools appearance.
Key exclusion criteria (6 listed)
- 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.),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saccharomyces cerevisiae CNCM I-38562 capsules daily, just before the breakfast with a glass of water, during 8 weeks. | Dietary supplement | Saccharomyces cerevisiae CNCM I-3856 |
| Placebo2 capsules daily, just before the breakfast with a glass of water, during 8 weeks. | Dietary supplement | Placebo |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2019.
- Derived from this study: PubMed 35979259Mourey 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle METREAU, MD principal investigator
Biofortis Mérieux NutriSciences
Arnaud BOURREILLE, Doctor principal investigator
Service d'Hépatogastroentérologie - CHU Nantes
Pierre DESREUMAUX, Professor principal investigator
Service de Gastroentérologie - Hôpital Huriez, CHU Lille
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saccharomyces cerevisiae CNCM I-3856 in people with Constipation-predominant Irritable Bowel Syndrome, run by Lesaffre International at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abdominal pain/discomfort score rated with Likert scale (ranging from 0 to 7) (time frame: Week 5 to Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03150212, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2019.