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NCT04884971 · ClinicalTrials.gov registry record · Phase 1
Microbiota Transplant Therapy for Pulmonary Arterial Hypertension: Early Safety and Feasibility Study
A Phase 1 study, sponsored by University of Minnesota.
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT04884971: Completed Phase 1 study, sponsored by University of Minnesota.
NCT04884971 is a Phase 1 study that has completed, run by University of Minnesota. The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04884971, a Phase 1 study, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
This pilot clinical trial will evaluate the initial safety and feasibility of intestinal microbiota transplantation (IMT) in patients with pulmonary arterial hypertension (PAH). This trial will inform development of future trials in treatment of PAH. Active drug in capsule form composed of freeze-dried, encapsulated intestinal microbiota from healthy donors will be administered to patients with PAH. This study will also allow for limited evaluation of pharmacokinetics in terms of donor microbiota engraftment and pharmacodynamics in terms of potential mechanisms. It will also allow for limited evaluation of cardiac endurance and function prior to and after IMT.
Primary Outcome
In order to assess the safety of the trial, the frequency of adverse events will be reported. Outcome will be reported as the mean number of serious adverse events per participant.
Interventions
- DRUG Intestinal microbiota transplant (IMT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2021-11-03 |
| Est. Completion | 2023-12-31 |
| Phase | Phase 1 |
What the finished NCT04884971 record still lists
NCT04884971 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 1 intervention - of which Intestinal microbiota transplant (IMT) is the first listed.
NCT04884971 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04884971 about?
NCT04884971 is a clinical study titled "Microbiota Transplant Therapy for Pulmonary Arterial Hypertension: Early Safety and Feasibility Study". This pilot clinical trial will evaluate the initial safety and feasibility of intestinal microbiota transplantation (IMT) in patients with pulmonary arterial hypertension (PAH). This trial will inform development of future trials in treatment of PAH. Active drug in capsule form composed of freeze-dr...
What is the current status of trial NCT04884971?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2021-11-03. Estimated completion is 2023-12-31.
What interventions are being tested in trial NCT04884971?
The interventions under investigation include: Intestinal microbiota transplant (IMT) (DRUG).
Who is sponsoring clinical trial NCT04884971?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04884971's enrollment target sits among peer trials
11 1911th of 2000 higher than 88 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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