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| ID | Type | Description | Link |
|---|---|---|---|
| ID RCB: 2011-A00915-36 | Other Identifier | French Health Products Safety Agency |
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| Name | Class |
|---|---|
| BioFortis | OTHER |
| University of Nottingham | OTHER |
The main purpose of this study is the effect of the probiotic yeast Saccharomyces cerevisiae CNCM I-3856 on abdominal pain or intestinal discomfort in patients presenting with the irritable bowel syndrome (IBS)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Dicalcium phosphate, Maltodextrin and Magnesium stearate. |
|
| Saccharomyces cerevisiae CNCM I-3856 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saccharomyces cerevisiae CNCM I-3856 | Dietary Supplement | 2 capsules/day during 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in discomfort score,obtained by Daily Likert Scale averaged by week | baseline and week 8 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David GENDRE, MD | BioFortis | Principal Investigator |
| Robin SPILLER, Professor of Gastroenterology | Nottingham Digestive Diseases Centre University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biofortis | Saint-Herblain | 44800 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27403301 | Derived | Spiller R, Pelerin F, Cayzeele Decherf A, Maudet C, Housez B, Cazaubiel M, Justen P. 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. doi: 10.1177/2050640615602571. Epub 2015 Aug 21. |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| Placebo | Dietary Supplement | Capsule with comparable organoleptic properties and weight than the experimental product. 2 capsules/day during 12 weeks |
|
| D004066 | Digestive System Diseases |