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The purpose of this study is to determine whether oral fecal microbiota transplantation (FMT) is safe for people with human immunodeficiency virus (HIV) infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral fecal microbiota transplantation | Experimental | All subjects will receive one dose per week for 6 weeks (6 total doses) of PRIM-DJ2727 oral capsules containing lyophilized microbiota product derived from 150 grams of healthy donor stool. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral fecal microbiota transplantation | Biological | All subjects will receive one dose per week for 6 weeks (6 total doses) of PRIM-DJ2727 oral capsules containing lyophilized microbiota product derived from 150 grams of healthy donor stool. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events related to study drug | 52 weeks | |
| Cumulative of adverse events related to study drug | 52 weeks | |
| Severity of adverse events related to study drug | Severity of adverse events will be based on Division of AIDS (DAIDS) grading criteria. | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the intestinal microbiome diversity | week 0, week 6 | |
| Change in the intestinal microbiome abundance of genera | week 0, week 6 | |
| Change in systemic inflammation as assessed by interleukin 6 (IL-6) levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Netanya S Utay, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Street Health Center | Houston | Texas | 77009 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33501400 | Derived | Utay NS, Monczor AN, Somasunderam A, Lupo S, Jiang ZD, Alexander AS, Finkelman M, Vigil KJ, Lake JE, Hanson B, DuPont HL, Arduino RC. Evaluation of Six Weekly Oral Fecal Microbiota Transplants in People with HIV. Pathog Immun. 2020 Dec 30;5(1):364-381. doi: 10.20411/pai.v5i1.388. eCollection 2020. |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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|
| week 0, week 6 |
| Change in microbial translocation as assessed by soluble cluster of differentiation (CD14) levels | week 0, week 6 |
| Change in gut barrier integrity as assessed by intestinal fatty acid binding protein (I-FABP) | week 0, week 6 |