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7 patients with active Ulcerative Colitis are treated with 25 multi-donor FMT Capsules daily for 50 days.
7 patients with active Ulcerative Colitis are treated with 25 multi-donor FMT Capsules daily for 50 days All patients are followed with regular follow up after 2,4,8,12,16, 20 and 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FMT treated patients | Experimental | Seven patients with active Ulcerative Colitis treated with 25 multi-donor FMT Capsules daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal Microbiota Transplantation Capsules | Other | 25 daily multi-donor FMT Capsules for 50 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in patient colitis symptoms as assessed using the Simple Colitis Clinical Activity Index (SCCAI) | Simple Colitis Clinical Activity Index (SCCAI) | Baseline, 2,8,16 and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fecal microbiota biodiversity in patients with Ulcerative Colitis and difference to donors fecal microbiota diversity | Alpha diversity (Shannon-index) | Baseline |
| Fecal microbiota biodiversity in fecal donors |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alice H Christensen, MD, PhD | Aleris-Hamlet Hospitals Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aleris-Hamlet Hospital Copenhagen | Søborg | 2860 | Denmark |
Data are available upon request
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 25, 2019 | |
| Reset | Jul 10, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 25, 2019 | Jul 10, 2019 |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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The trial is an open-label pilot study treating 7 patients with Ulcerative Colitis with 25 daily multi-donor FMT Capsules for 50 days with 6 months follow up including the treatment period
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Alpha diversity (Shannon-index)
| At donor inclusion |
| Changes in fecal microbiota biodiversity in patients with Ulcerative Colitis in comparison with value at baseline | Alpha diversity (Shannon-index) | 8, 16 and 24 weeks |
| Changes in Fecal Calprotectin in the active treatment period and follow-up period | Fecal Calprotectin | Baseline, 8,16 and 24 weeks |
| Changes in patient reported quality of life: IBDQ | Inflammatory Bowel Disease Questionnaire (IBDQ) | Baseline, 8, 16 and 24 weeks |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |