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Microbiota Transplant Therapy for Pulmonary Arterial Hypertension

This study is testing a new approach for pulmonary arterial hypertension (PAH). It's looking at the safety and how well your body handles microbiota transplant therapy (MTT) in capsule form, which contains healthy donor gut bacteria. Some participants will also receive antibiotics and fiber. The study aims to see if this treatment can help with PAH. We are looking for 24 participants aged 18 to 75 who have PAH and are on stable treatment. The main goal is to see how well the healthy donor bacteria "take hold" in your gut after 12 weeks.

Study design
This is a randomized study, meaning participants are assigned by chance to one of three groups: MTT with antibiotics and fiber, MTT with antibiotics and a placebo, or two placebos. It plans to enroll 24 participants.
What's involved
You would take capsules (MTT or placebo) and potentially a fiber supplement. You would have follow-up visits at weeks 1, 2, 4, 12, and 24, and provide blood and stool samples at certain times.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 24 weeks after starting treatment, with the main assessment for donor bacteria engraftment at week 12.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06481852

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

Recruiting
PHASE1Ages 18–75InterventionalSupportive care
University of Minnesota
~24 participants
Updated 2026-07-31 on ClinicalTrials.gov
What's tested:MTT with antibiotic preconditioning + fiber supplementationMTT with antibiotic preconditioning + placebo supplementationMTT with placebo + placebo supplementation.

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
donor engraftment comparison
Measured over week 12

Conditions

Pulmonary Arterial Hypertension

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NCT06481852

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Minnesota

    Minneapolis, Minnesotano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Thenappan Thenappan, MD · PRINCIPAL_INVESTIGATOR · University of Minnesota
  • Levi Teigen, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Minnesota
  • Alexander Khoruts, MD · PRINCIPAL_INVESTIGATOR · University of Minnesota
  • Christopher Staley, PhD · PRINCIPAL_INVESTIGATOR · University of Minnesota
  • Kurt Prins, MD,PhD · PRINCIPAL_INVESTIGATOR · University of Minnesota
  • Edward Weirs, MD · PRINCIPAL_INVESTIGATOR · University of Minnesota

Who to contact

Gretchen Peichel
[email protected]
Email the study team

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Eligibility criteria

Inclusion

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 availability for the duration of trial to follow-up by telephone, in-person, email, and/or video visits or correspondence.

Exclusion

Dysphagia to pills
Clinically active inflammatory bowel disease
Pregnancy or breastfeeding. A pregnancy test will be obtained from females of child- bearing potential at the screening visit or day 1 (prior to the receipt of MTT). Patients with a positive pregnancy test will be excluded. A negative result will be required for subjects who are females of child-bearing potential to receive MTT. Patients will be counseled to avoid pregnancy which is the standard of care for patients with PAH.
Life expectancy of \< 6 months
Presence of ileostomy or colostomy
Patients on immunosuppressants (calcineurin inhibitors, prednisone ≥ 20 mg/day, methotrexate, azathioprine, immunosuppressive biologics, JAK inhibitors).
Patients with neutropenia (an absolute neutrophil count \< 0.5 x 10 9 cells/L) obtained on a complete blood count with differential at screening
History of solid organ or bone marrow transplant
Anticipated recurrent antibiotic use (patients with frequent urinary tract infections or sinusitis)
History of severe anaphylactic food allergy
History of celiac disease
Patients receiving cancer chemotherapy, immunotherapy, or radiation
Patients with severe Irritable bowel syndrome (IBS) defined by an IBS score \>250

What this trial measures

  • donor engraftment comparisonweek 12

    The difference in donor microbiota engraftment between the three study groups at week 12