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| Name | Class |
|---|---|
| OpenBiome | INDUSTRY |
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This is a randomized pilot study to characterize engraftment of a donor's microflora onto patients with Irritable Bowel Syndrome with diarrhea following fecal microbiota transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fecal microbiota transplantation | Experimental | fecal microbiota transplantation |
|
| placebo fecal microbiota transplantation | Placebo Comparator | placebo fecal microbiota transplantation |
|
| FMT after antibiotic pretreatment v1 | Experimental | fecal microbiota transplantation after antibiotic pretreatment |
|
| FMT after antibiotic pretreatment v2 | Experimental | fecal microbiota transplantation after antibiotic pretreatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fecal microbiota transplantation | Procedure | fecal microbiota transplantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| stable engraftment of donor microbiota | Stable engraftment will be defined with the Jensen-Shannon Divergence (JSD) between the bacteria community measured in the donor and recipient. Engraftment scores will be defined by the ratio between the JSD in comparison between the recipient and donor and the recipient and other healthy donors not providing material for their FMT. | 10 weeks |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Lembo, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35014601 | Derived | Singh P, Alm EJ, Kelley JM, Cheng V, Smith M, Kassam Z, Nee J, Iturrino J, Lembo A. Effect of antibiotic pretreatment on bacterial engraftment after Fecal Microbiota Transplant (FMT) in IBS-D. Gut Microbes. 2022 Jan-Dec;14(1):2020067. doi: 10.1080/19490976.2021.2020067. |
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| placebo fecal microbiota transplantation | Drug | placebo fecal microbiota transplantation |
|
| FMT with antibiotic pre-treatment (v1) | Procedure | FMT with antibiotic pre-treatment (v1) |
|
| FMT with antibiotic pre-treatment (v2) | Procedure | FMT with antibiotic pre-treatment (v2) |
|
| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| C065700 | myotrophin |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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