Not provided
Not provided
Not provided
Not provided
Not provided
Problems in recruiting
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 purpose of this study is to find out whether a single fecal microbiota transplantation is an effective and safe treatment as an adjunct to standard therapy in patients with ulcerative colitis.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fecal microbiota transplantation | Active Comparator | A single fecal microbiota transplantation via colonoscope as an adjunct therapy to standard medical treatment |
|
| Standard medical treatment | No Intervention | Standard medical treatment as recommended by the ECCO Guidelines of UC therapy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal microbiota transplantation | Other | A single fecal microbiota transplantation through colonoscope |
|
| Measure | Description | Time Frame |
|---|---|---|
| Activity of ulcerative colitis | Change from baseline in the Pediatric Ulcerative Colitis Activity Index (PUCAI) at 1 month, 3 months, 6 months, and 12 months. | Within 1 year after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Colonic inflammation | Change from baseline in the fecal calprotectin at 1 month, 3 months, 6 months, and 12 months. | Within 1 year after the intervention |
| Colonic inflammation | Endoscopic Mayo score at 3 and 12 months after the intervention |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marko Kalliomäki, MD | Turku University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Turku University Hospital | Turku | 20520 | Finland |
Not provided
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Within 1 year after the intervention |
| Adverse events | Within 1 year after the intervention |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |