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Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in PAH.

StatusActive, Not Recruiting
PhasePhase 1
Started
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Record History

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  1. Notable Start date pushed from Apr 1, 2026 to Sep 1, 2026
    • Trial status changed: Not Yet Recruiting → Active, Not Recruiting
  2. Minor Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Start date changed from estimate of Sep 1, 2026 to Apr 1, 2026
    • Eligibility criteria expanded, about 14 words
    • Site contact updated
  3. Minor Re-verified, no change to tracked fieldsv2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This pilot clinical trial analysis 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.
Trial Details
NCT Number NCT07751120
Lead Sponsor University of Minnesota
Conditions
(from sponsor)
Pulmonary Arterial Hypertension
Related terms Pulmonary Arterial Hypertension
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov