A Phase 1 interventional study of MTT with antibiotic preconditioning + fiber supplementation and MTT with antibiotic preconditioning + placebo supplementation in Pulmonary Arterial Hypertension, sponsored by University of Minnesota. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by University of Minnesota · Phase 1, Interventional, and Supportive care
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.
Exclusion Criteria:
PAH patients randomized to MTT with antibiotic preconditioning + fiber supplementation
Drug: MTT with antibiotic preconditioning + fiber supplementation
MTT with antibiotic preconditioning + placebo supplementation
Drug: MTT with antibiotic preconditioning + placebo supplementation
placebo + placebo supplementation.
Drug: MTT with 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.
MTT will in a capsule form composed of freeze-dried, encapsulated intestinal microbiota from healthy donors. 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.
MTT will in a capsule form composed of freeze-dried, encapsulated intestinal microbiota from healthy donors. 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.
Donor engraftment comparison
The difference in donor microbiota engraftment between the three study groups at week 12
Time frame: Week 12
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
Time frame: 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
Time frame: Week 12
Change in inflammatory markers
The differences in the change in circulating markers of inflammation (serum CRP and cytokine levels) and microbial metabolites (short chain fatty acids, secondary bile acids, and trimethylamine oxide) from baseline to week 12 between the three study groups.
Time frame: From Baseline to 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
Time frame: 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
Time frame: 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
Time frame: Week 12
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Pulmonary Arterial Hypertension→
University of Minnesota