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IND required by the FDA for all future FMTs.
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| Name | Class |
|---|---|
| The Broad Foundation | OTHER |
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Fecal microbiota therapy (FMT) is an emerging treatment for gastrointestinal disorders marked by an imbalance in the intestinal microbial flora (dysbiosis). It is hypothesized to work by shifting the recipient's microbiota toward a eubiotic microbial community that resists colonization by pathogenic organisms or decreases its inherent inflammatory properties. Several studies now report its efficacy in treatment of severe Clostridium difficile colitis. Preliminary studies using FMT in Ulcerative Colitis (UC) have also met with some success. This is corroborated by several lines of evidence suggesting dysbiosis plays an important role in UC pathogenesis. While a recent study using FMT in patients with irritable bowel syndrome (IBS) and constipation found transplants persist for up to 2 years, the extent to which the microbiota is alterable in UC is not known. Indeed, there may be particular genetic or immunologic factors in UC leading to selection pressure preventing a change in the microbiota. As an initial step into investigating the potential efficacy of stool transplants for Ulcerative Colitis (UC), the investigators propose to determine the feasibility and stability of transplanted microbiota in a series of 10 patients with mild to moderate UC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fecal Microbiota Transplantation | Experimental | Fecal Microbiota Transplantation by colonoscopic delivery of stool to the right colon. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal Microbiota Transplantation | Other | Fecal microbiota transplantation by colonoscopic administration of 300cc of fecal slurry from healthy donor to the right colon. |
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| Measure | Description | Time Frame |
|---|---|---|
| Successful engraftment of donor fecal microbiota at 4 weeks post-transplantation. | Metagenomic shotgun sequencing using Iluminia technology will be used to evaluate for engraftment. Metagenomic data will be analyzed using CompareReads. A % similarity to the recipient > than % similarity to the donor will be defined as engraftment. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Engraftment of fecal microbiota transplantation at 7 days. | As in primary aim but at 7 days. | 7 days |
| Durability of Fecal Microbiota Transplantation at 12 weeks | As in primary aim but at 12 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy L Zisman, MD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23034604 | Background | Damman CJ, Miller SI, Surawicz CM, Zisman TL. The microbiome and inflammatory bowel disease: is there a therapeutic role for fecal microbiota transplantation? Am J Gastroenterol. 2012 Oct;107(10):1452-9. doi: 10.1038/ajg.2012.93. | |
| 26288277 | Derived | Damman CJ, Brittnacher MJ, Westerhoff M, Hayden HS, Radey M, Hager KR, Marquis SR, Miller SI, Zisman TL. Low Level Engraftment and Improvement following a Single Colonoscopic Administration of Fecal Microbiota to Patients with Ulcerative Colitis. PLoS One. 2015 Aug 19;10(8):e0133925. doi: 10.1371/journal.pone.0133925. eCollection 2015. |
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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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| 12 weeks |
| Clinical remission at 4 weeks. | Defined as Mayo score <=2 with no subscore >1 | 4 weeks |
| Clinical remission at 12 weeks. | Defined as Mayo score <=2 with no subscore >1 | 12 weeks |
| Endoscopic remission at 4 weeks. | Mayo endoscopy scope of 0. | 4 weeks |
| Number of patients with worsened disease. | Increase in Mayo score of >2. | 4 weeks. |
| Number of adverse events. | 12 weeks. |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |