Actively Recruiting
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
Led by University of Minnesota · Updated on 2025-10-15
24
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated consent form
- Age between 18 and 75 years
- Diagnosed with pulmonary arterial hypertension (PAH)
- On stable PAH treatment for at least one month before enrollment
- Able to swallow capsules
- Able to provide blood and fecal samples
- Willing to comply with all study procedures and available for follow-up by phone, in-person, email, or video visits
You will not qualify if you...
- Difficulty swallowing pills
- Active inflammatory bowel disease
- Pregnant or breastfeeding; females of childbearing potential must have a negative pregnancy test before receiving MTT
- Life expectancy less than 6 months
- Presence of ileostomy or colostomy
- Use of immunosuppressant medications such as calcineurin inhibitors, prednisone 20 mg/day or more, methotrexate, azathioprine, immunosuppressive biologics, or JAK inhibitors
- Neutropenia with absolute neutrophil count below 0.5 x 10^9 cells/L
- History of solid organ or bone marrow transplant
- Expected frequent antibiotic use (e.g., frequent urinary tract infections or sinusitis)
- History of severe anaphylactic food allergy
- History of celiac disease
- Receiving cancer chemotherapy, immunotherapy, or radiation
- Severe irritable bowel syndrome with IBS score over 250
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Minnesota
Minneapolis, Minnesota, United States, 55414
Actively Recruiting
Research Team
G
Gretchen Peichel
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
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