Pilot Study of Microbiota Transplant Therapy With Antibiotic Preconditioning and Fiber Supplementation Compared to Placebo in Adults With Pulmonary Arterial Hypertension

What this Trial Is About

Researchers are evaluating microbiota transplant therapy MTT combined with antibiotic preconditioning and fiber supplementation in adults with pulmonary arterial hypertension PAH. This pilot clinical trial aims to assess the initial safety, feasibility, and how the body processes this treatment compared to placebo. The study will help guide future research on using MTT as a potential treatment for PAH. Participants are randomly assigned to one of three groups MTT with antibiotic preconditioning plus fiber supplementation, MTT with antibiotic preconditioning plus placebo supplementation, or placebo with placebo supplementation. MTT is given as capsules containing freeze-dried intestinal microbiota from healthy donors, and fiber supplementation is an oral dose of 10-14 grams. Treatment and follow-up visits are scheduled at weeks 1, 2, 4, 12, and 24. During the study, participants will provide stool and blood samples at multiple time points to monitor changes. They will also undergo an echocardiogram, six-minute walk test, and quality of life questionnaire at the start and at week 12. The research team will measure donor microbiota engraftment, safety, feasibility, inflammatory markers, and heart function. The entire participation may last up to 24 weeks, including various assessments and monitoring.

A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)