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
NCT Number: NCT06481852
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Pulmonary Arterial Hypertension
Interventions: DRUG: MTT with antibiotic preconditioning + fiber supplementation|DRUG: MTT with antibiotic preconditioning + placebo supplementation|OTHER: MTT with placebo + placebo supplementation.
Sponsor: University of Minnesota
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-01
Completion Date: 2026-09-01

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 Measures: donor engraftment comparison, The difference in donor microbiota engraftment between the three study groups at week 12, week 12
Secondary Outcome Measures: safety of MTT with antibiotic preconditioning and fiber supplementation in patients with PAH, The difference in frequency of serious adverse events and other adverse events between the three study groups, week 12|feasibility of MTT with antibiotic preconditioning and fiber supplementation in patients with PAH, The differences in proportion of subjects taking 100% of the MTT per protocol between the three study groups, week 12|change in inflammatory markers, The differences in the change in circulating markers of inflammation and microbial metabolites from baseline to week 12 between the three study groups, week 12|compare right ventricular function, measure 1, The differences in the change in six-minute walk distance (6MWD) from baseline to week 12 between the three study groups, week 12|compare right ventricular function, The differences in the change in right ventricular ejection fraction from baseline to week 12 between the three study groups, week 12|compare right ventricular function, The differences in the change in quality of life survey from baseline to week 12 between the three study groups, week 12