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NCT06481852 · ClinicalTrials.gov registry record · Phase 1
A Placebo-controlled, Randomized Clinical Trial to Assess the Safety, Feasibility, and Pharmacokinetics of Microbiota Transplant Therapy With Antibiotic Preconditioning and Fiber Supplementation in Patients With Pulmonary Arterial Hypertension
A Phase 1 study of Pulmonary Arterial Hypertension, sponsored by University of Minnesota.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT06481852: Recruiting Phase 1 study of Pulmonary Arterial Hypertension, sponsored by University of Minnesota.
NCT06481852 is a Phase 1 study of Pulmonary Arterial Hypertension that is actively recruiting participants, run by University of Minnesota. The registered enrollment target is 24 participants, below the 462-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06481852, a Phase 1 study of Pulmonary Arterial Hypertension, is actively recruiting participants, sponsored by University of Minnesota.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
This pilot clinical trial will evaluate the initial safety, feasibility, and pharmacokinetics of microbiota transplant therapy (MTT) with antibiotic pre-conditioning and fiber supplementation vs. placebo in patients with pulmonary arterial hypertension (PAH). This trial will inform development of future trials of MTT as a treatment for PAH. 24 PAH patients will be randomized to receive either MTT with antibiotic preconditioning + fiber supplementation, MTT with antibiotic preconditioning + placebo supplementation, or placebo + placebo supplementation. MTT will in a capsule form composed of freeze-dried, encapsulated intestinal microbiota from healthy donors. Fiber supplementation will be 10-14 gm oral fiber supplement. Patients will be followed at week 1, week 2, week 4, week 12, and week 24. Patient will undergo stool sample collection at baseline, week 1, week 4, and week 12, blood sample collection at baseline, week 4, and week,12. In addition, patient will undergo an echocardiogram, six-minute walk test (6MWT) and quality of life questionnaire at baseline and at week 12.
Primary Outcome
The difference in donor microbiota engraftment between the three study groups at week 12
Conditions Studied
Interventions
- DRUG MTT with antibiotic preconditioning + fiber supplementation
- DRUG MTT with antibiotic preconditioning + placebo supplementation
- OTHER MTT with placebo + placebo supplementation.
Study Locations (1)
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2024-10-28 |
| Est. Completion | 2027-04-30 |
| Phase | Phase 1 |
What NCT06481852 shows while recruiting
NCT06481852 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 462-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Pulmonary Arterial Hypertension appearing as the primary indexed condition, and to 3 interventions - of which MTT with antibiotic preconditioning + fiber supplementation is the first listed.
NCT06481852 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT06481852 about?
NCT06481852 is a clinical study titled "A Placebo-controlled, Randomized Clinical Trial to Assess the Safety, Feasibility, and Pharmacokinetics of Microbiota Transplant Therapy With Antibiotic Preconditioning and Fiber Supplementation in Patients With Pulmonary Arterial Hypertension". This pilot clinical trial will evaluate the initial safety, feasibility, and pharmacokinetics of microbiota transplant therapy (MTT) with antibiotic pre-conditioning and fiber supplementation vs. placebo in patients with pulmonary arterial hypertension (PAH). This trial will inform development of fu...
What is the current status of trial NCT06481852?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2024-10-28. Estimated completion is 2027-04-30.
What conditions does trial NCT06481852 study?
This clinical trial studies the following conditions: Pulmonary Arterial Hypertension.
What interventions are being tested in trial NCT06481852?
The interventions under investigation include: MTT with antibiotic preconditioning + fiber supplementation (DRUG), MTT with antibiotic preconditioning + placebo supplementation (DRUG), MTT with placebo + placebo supplementation. (OTHER).
Who is sponsoring clinical trial NCT06481852?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06481852 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06481852's enrollment target sits among peer trials
24 48th of 63 higher than 16 of 63 other Pulmonary Arterial Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pulmonary Arterial Hypertension 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.
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