A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Recruiting
Phase 1
Interventional Study
Pulmonary Arterial Hypertension
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Supportive Care
- Participants needed
- 24 (estimated)
- Sponsor
- University of Minnesota · Other
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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
* Stated willingness to comply with all study procedures and av…
Contacts