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| Name | Class |
|---|---|
| Helsinki University Central Hospital | OTHER |
| University of Helsinki | OTHER |
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Adult individuals with ulcerative colitis in remission are given a single fecal microbiota transplantation (FMT) in colonoscopy. A half of the patients will receive autologous FMT as a placebo and a half will receive an FMT from a healthy donor.
80 adult patients with ulcerative colitis (UC) will be recruited. They are randomized to receive either an autologous FMT as a placebo or FMT from a healthy donor (frozen and thawed).
The patients are followed up with fecal samples to detect microbial changes. The follow up lasts 1 year after the FMT and a follow up colonoscopy will be done 52 weeks after the FMT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FMT | Active Comparator | 50% of the participants will receive fecal suspension of a healthy donor administered in colonoscopy into the cecum |
|
| Placebo | Placebo Comparator | 50% of the participants will receive fecal suspension made of their own feces administered in colonoscopy into the cecum. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal microbiota transplantation (FMT) | Other | FMT administered into the cecum of the patient in colonoscopy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maintenance of remission of ulcerative colitis | Endoscopic remission and Mayo-score < 2 | 52 weeks |
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Inclusion Criteria:
• • Diagnosis of CU based on clinical, endoscopic, and histological findings.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Hospital | Helsinki | Finland | ||||
| Päijät-Häme Central Hospital |
Individual participant data will not be shared.
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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 |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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Participants are randomized in two groups to receive in colonoscopy either a fecal suspension made of their own feces or a fecal suspension of a healthy donor.
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The participant and the treating personnel are blinded of the randomization result.
| Placebo | Other | Autologous FMT (fecal suspension made of patients own feces) administered into the cecum of the patient in colonoscopy. |
|
| Lahti |
| Finland |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |