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| Name | Class |
|---|---|
| University of Calgary | OTHER |
| McMaster University | OTHER |
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To determine the efficacy and safety of serial FMT at inducing and maintaining clinical and endoscopic response in patients with mild to moderate Crohn's disease
Double blind study will randomize patients with mild to moderate Crohn's 1:1 (FMT : water) stratified by disease duration and current use of biologic therapy. First FMT/placebo at week 0 by colonoscopy plus weekly FMT/placebo by capsules for 7 weeks. At week 8, a repeat colonoscopy will be done and endoscopy score repeated.
Responders in FMT arm are eligible to enter open label phase to receive FMT by capsules q2 weeks.
Blood, stool and urine samples, colonic biopsies will be collected. Quality of Life as measured by Short Inflammatory Bowel Disease Questionnaire, EuroQol five dimensions, and Work Productivity and Activity Impairment Questionnaire: Crohns disease and dietary intake diary collected.
Colonoscopies recorded and reviewed by a central reader.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fecal microbiota transplant | Experimental | Transfer of healthy human gut bacteria |
|
| Placebo | Placebo Comparator | Water |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal Microbiota Transplant (FMT) | Biological | FMT delivered by colonoscopy and oral capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical and Endoscopic Remission | Harvey Bradshaw Index <5 and Simple endoscopic score <5 | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response | Harvey Bradshaw Index reduction by 3 points | Week 8 |
| Clinical remission | Harvey Bradshaw Index <5 | Week 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dina Kao, MD | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foothills Hospital | Calgary | Alberta | T2N2T9 | Canada | ||
| University of Alberta |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39530534 | Derived | Kao D, Wong K, Jijon H, Moayyedi P, Franz R, McDougall C, Hotte N, Panaccione R, Semlacher E, Kroeker KI, Peerani F, MacDonald KV, Xu H, Narula N, Turbide C, Marshall DA, Madsen KL. Preliminary Results From a Multicenter, Randomized Trial Using Fecal Microbiota Transplantation to Induce Remission in Patients With Mild-to-Moderate Crohn's Disease. Am J Gastroenterol. 2024 Nov 12;120(6):1334-1344. doi: 10.14309/ajg.0000000000003196. |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| Placebo | Biological | Transfer of water only |
|
| Endoscopic response | Simple endoscopic score reduction by 50% | Week 8 |
| Endoscopic remission | Simple endoscopic score <5 | Week 8 |
| Quality of Life 1 | Mean changes in Short Inflammatory Bowel Disease Questionnaire | Week 8 |
| Quality of Life 2 | Mean changes in Euro five dimensions questionnaire | Week 8 |
| Quality of Life 3 | Mean changes in Work Productivity and Activity Impairment: Crohns Disease questionnaire | Week 8 |
| Edmonton |
| Alberta |
| T6G 2X8 |
| Canada |
| McMaster University | Hamilton | Ontario | Canada |