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| ID | Type | Description | Link |
|---|---|---|---|
| 35RC14_9817_EMMENTAL | Other Identifier | CHU de Rennes |
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Recruitment difficulties
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Ulcerative colitis (UC) is an immune mediated chronic inflammatory bowel disease that results at least in part of an abnormal immune response to environmental factors including the intestinal microbiota. Thus, use of probiotics (microorganisms that are believed to provide health benefits when consume) may restore the gastrointestinal microbiota and reduce intestinal inflammation.
Propionibacterium freudenreichii is used for the production of fermented food products (cheese). Some selected strains have strong anti-inflammatory properties. Use of cheese based on a monoxenic culture of anti-inflammatory strain of Propionibacterium freudenreichii may decrease disease activity during ulcerative colitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotics | Experimental | Oral daily take of probiotics in the form of cheese portion (50g) during 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotics in the form of cheese portion | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | Response rate is defined by a decrease of at least two points of the Simple Clinical Colitis Index (SCCI) | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of clinical response | Week 4 | |
| Rate of clinical remission | Clinical remission rate is defined by a SCCI<3 | Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Rennes | Rennes | 35033 | France |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Rate of clinical remission |
Clinical remission rate is defined by a SCCI<3 |
| Week 8 |
| Rate of mucosal healing | Mucosal Healing is defined by a Mayo endoscopic subscore of 0 or 1 | Week 8 |
| Rate of deep (clinical and endoscopic) remission | Deep remission is defined clinically and by endoscopic exams | Week 8 |
| Side effects | Assessment of adverse events | Week 8 |
| Rate of response based on presence of Proprionibacterium freudenreichii in stools at week 0 | Proprionibacterium freudenreichii analysis in stools | Week 8 |
| Remission rate based on presence of Proprionibacterium freudenreichii in stools at week 0 | Proprionibacterium freudenreichii analysis in stools | Week 8 |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D019602 |
| Food and Beverages |