Trials / Completed
CompletedNCT03329560
Safety of FMT Using Oral Encapsulated PRIM-DJ2727 in HIV
Safety of Fecal Microbiota Transplant Using Oral Encapsulated PRIM-DJ2727 in HIV-infected Persons on Antiretroviral Therapy
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- The University of Texas Health Science Center, Houston · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine whether oral fecal microbiota transplantation (FMT) is safe for people with human immunodeficiency virus (HIV) infection.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Oral fecal microbiota transplantation | 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. |
Timeline
- Start date
- 2018-04-12
- Primary completion
- 2019-10-08
- Completion
- 2019-10-08
- First posted
- 2017-11-06
- Last updated
- 2020-05-27
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03329560. Inclusion in this directory is not an endorsement.