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The purpose of the study is to evaluate the efficacy and safety of lyophilized PRIM-DJ2727 capsules given orally in subjects with ulcerative colitis at remission stage. This study will also include longitudinal analyses of recipient's gut microbiota taxonomy and metagenomics to determine potential associations with clinical outcomes in context of active FMT or placebo administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with UC will receive FMT capsules | Experimental | Patients with ulcerative colitis will receive fecal microbiota capsules from 3 healthy donors |
|
| Patients with UC will receive placebo | Placebo Comparator | Patients with ulcerative colitis will receive matching placebo capsules. Placebo capsule will be identical to PRIM-DJ2727 but will not contain intestinal bacteria. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRIM-DJ2727 | Drug | Fecal Microbiota Transplantation (FMT) product manufactured as PRIM-DJ2727 capsules consists of lyophilized microbiota suspension from well-screened donors. Microbiota from three donors will be combined to make the product. |
| Measure | Description | Time Frame |
|---|---|---|
| Patients in remission after administering 12 weeks of PRIM-DJ2727 capsules will be measured by partial Mayo score ≤ 3 | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life will be characterized by health-related quality of life score. | 9 months | |
| Subject-reported score in Hospital Anxiety and Depression Scale | After administering 12 weeks of PRIM-DJ2727 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Herbert DuPont, md | Contact | 713 500 6687 | herbert.l.dupont@uth.tmc.edu | |
| Zhi-Dong Jiang, Dr.PH | Contact | 713 500 9371 | zhi-dong.jiang@uth.tmc.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Recruiting | Houston | Texas | 77030 | United States |
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| Placebos | Drug | Placebo capsule will be identical to PRIM-DJ2727 but will not contain intestinal bacteria. |
|
| 9 months |