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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Manipulation of the intestinal microbiota through FMT is a potential therapeutic target for IBD patients. Studies are now required to determine if repeated FMT can overcome the apparent immune response to FMT thereby maintaining sustained clinical improvement and remission. Prior to a large randomized controlled trial of FMT in UC we will carry out a feasibility study to determine if serial FMTs can sustain a clinical response and maintain stability of transplanted microbiota.
same as above
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fecal Microbiota Transplantation | Experimental | serial Fecal Microbiota Transplantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal Microbiota Transplant | Biological | serial FMT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mayo score reduction | Patients with at least 3 point reduction in partial Mayo scoring index at week 12 and at week 32 in the extension phase. | 12 and 32 weeks |
Not provided
Not provided
Inclusion Criteria:
Age > 18 and < 65 years
Diagnosis of UC for > 3 months but < 5 years prior to screening as determined by the investigators
Those with mild to moderate UC
Those who have failed maintenance therapy with stable doses of 5-ASA, azathioprine or 6 mercaptopurine (6-MP) for > 3 months
Where applicable, those who are taking the following medications must be at a stable dose defined as:
i) 5-ASA must be at a stable dose for 2 weeks ii) Prednisone up to 20 mg/d must be at a stable dose for 2 weeks iii) Budesonide up to 6 mg/d must be at a stable dose for 2 weeks iv) Azathioprine or 6-MP must be at a stable dose for > 8 weeks
ability to provide informed consent
evidence of active inflammation
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dina Kao, MD | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta Hospital | Edmonton | Alberta | Canada |
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
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |