Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saccharomyces cerevisiae CNCM I-3856 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saccharomyces cerevisiae CNCM I-3856 | Dietary Supplement | 2 capsules daily, just before the breakfast with a glass of water, during 8 weeks. |
|
| 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 |
Not provided
Not provided
Inclusion Criteria:
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:
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"),
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General pratices | France | France | ||||
| Eurofins Optimed |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35979259 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Double blind
| Placebo | Dietary Supplement | 2 capsules daily, just before the breakfast with a glass of water, during 8 weeks. |
|
| Gières |
| France |
| Créabio Rhône Alpes | Givors | France |
| Institut Pasteur de Lille | Lille | France |
| Biofortis Mérieux NutriSciences | Saint-Herblain | 44800 | France |