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NCT02256592 · ClinicalTrials.gov registry record · Phase 1
Fecal Microbiota Transplantation in HIV
A Phase 1 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT02256592: Completed Phase 1 study, sponsored by University of California, San Francisco.
NCT02256592 is a Phase 1 study that has completed, run by University of California, San Francisco. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02256592, a Phase 1 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
Even in individuals treated for HIV, chronic immune activation persists and is associated with increased cardiovascular disease, liver disease, and mortality. HIV-infected individuals have imbalances in the community of intestinal microbes which is thought to contribute to increased and persistent inflammation. The purpose of this study is to examine the safety and durability of fecal microbiota transplant (FMT), the transfer of the bacterial community in stool from a healthy donor, in HIV+ individuals on anti-retroviral therapy. The study will also measure the effects of FMT on immune activation and inflammatory biomarkers in anti-retroviral treated HIV+ individuals.
Primary Outcome
Determine the proportion of individuals with AE/SAE. Record AE/SAE during FMT and post-FMT and determine if related to study procedure and graded for severity. Study stoppage criteria includes any serious AE that is at least possibly related to study treatment or any serious infection (e.g., bacteremia) in a sterile body site with an organism potentially acquired from the FMT product.
Interventions
- DRUG Fecal Microbiota
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2014-10 |
| Est. Completion | 2017-03 |
| Phase | Phase 1 |
What the finished NCT02256592 record still lists
NCT02256592 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 1 intervention - of which Fecal Microbiota is the first listed.
NCT02256592 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02256592 about?
NCT02256592 is a clinical study titled "Fecal Microbiota Transplantation in HIV". Even in individuals treated for HIV, chronic immune activation persists and is associated with increased cardiovascular disease, liver disease, and mortality. HIV-infected individuals have imbalances in the community of intestinal microbes which is thought to contribute to increased and persistent i...
What is the current status of trial NCT02256592?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2014-10. Estimated completion is 2017-03.
What interventions are being tested in trial NCT02256592?
The interventions under investigation include: Fecal Microbiota (DRUG).
Who is sponsoring clinical trial NCT02256592?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02256592's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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