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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 is a Phase 1 study that has completed, run by University of Minnesota. The registered enrollment target is 11 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04884971
The ClinicalTrials.gov registry entry for NCT04884971 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Intestinal microbiota transplant (IMT) is the first listed.
NCT04884971 reports 0 study locations.
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.
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