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
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, feasibility, and pharmacokinetics of microbiota transplant therapy (MTT) combined with antibiotic preconditioning and fiber supplementation in adults with pulmonary arterial hypertension (PAH). This pilot clinical trial will help guide future studies of MTT as a potential treatment for PAH by comparing it to placebo treatment. The study is randomized, placebo-controlled, and double-blind, involving 24 patients with PAH. Participants will be assigned to one of three groups: MTT with antibiotic preconditioning plus fiber supplementation, MTT with antibiotic preconditioning plus placebo supplementation, or placebo plus placebo supplementation. MTT is given as capsules containing freeze-dried intestinal microbiota from healthy donors, and fiber supplements will be 10 to 14 grams taken orally. Follow-up visits occur at weeks 1, 2, 4, 12, and 24. Stool and blood samples are collected at specified times, and patients undergo echocardiograms, six-minute walk tests, and quality of life questionnaires at baseline and week 12. During the study, patients provide stool samples at baseline, week 1, week 4, and week 12, and blood samples at baseline, week 4, and week 12. They complete functional assessments such as echocardiograms and six-minute walk tests and answer quality of life questionnaires. The main outcome is donor microbiota engraftment at week 12. Safety, feasibility, inflammatory markers, and right ventricular function are also evaluated. The total participation duration includes follow-up to week 24, with monitoring by telephone, in-person, email, or video visits.
CONDITIONS
Brief 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...
- Provision of signed and dated consent form
- Ages 18-75
- Diagnosis of PAH
- On stable treatment for PAH for one month prior to enrollment
- Able to swallow capsules
- Able to provide blood sample and fecal sample
- Willingness to comply with all study procedures and availability for follow-up by telephone, in-person, email, and/or video visits or correspondence
You will not qualify if you...
- Dysphagia to pills
- Clinically active inflammatory bowel disease
- Pregnancy or breastfeeding
- Life expectancy of less than 6 months
- Presence of ileostomy or colostomy
- Use of immunosuppressants such as calcineurin inhibitors, prednisone 20 mg/day or more, methotrexate, azathioprine, immunosuppressive biologics, or JAK inhibitors
- Neutropenia (absolute neutrophil count less than 0.5 x 10^9 cells/L)
- History of solid organ or bone marrow transplant
- Anticipated recurrent 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 defined by an IBS score over 250
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive microbiota transplant therapy with antibiotic preconditioning and either fiber supplementation, placebo supplementation, or placebo capsules. They take capsules and supplements as part of the treatment.
Visits at week 1, week 2, week 4, week 12, and week 24
Duration - Up to week 24 after treatment starts
Participants undergo assessments including stool and blood sample collections, echocardiogram, six-minute walk test, and quality of life questionnaires to monitor safety, feasibility, and treatment effects.
Sample collections at baseline, week 1, week 4, and week 12; blood samples at baseline, week 4, and week 12; clinical assessments at baseline and week 12
Trial Site Locations
Total: 1 location
1
University of Minnesota
Minneapolis, Minnesota, United States, 55414
Actively Recruiting
Research Team
G
Gretchen Peichel
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here