Recruiting

Phase 1

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

Sponsor:

University of Minnesota

Code:

NCT06481852

Conditions

Pulmonary Arterial Hypertension

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

MTT with antibiotic preconditioning + fiber supplementation

MTT with antibiotic preconditioning + placebo supplementation

MTT with placebo + placebo supplementation.

Study Details

Brief summary:

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

Pulmonary Arterial Hypertension

Study ID

NCT06481852

Start date

Oct 28, 2024

Status verified date

Jul, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Exclusion Criteria:

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

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Drug group

PAH patients randomized to MTT with antibiotic preconditioning + fiber supplementation

active comparator: Control 1

MTT with antibiotic preconditioning + placebo supplementation

placebo comparator: Control 2

placebo + placebo supplementation.

Interventions

MTT with antibiotic preconditioning + fiber 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.

MTT with antibiotic preconditioning + placebo supplementation

MTT will in a capsule form composed of freeze-dried, encapsulated intestinal microbiota from healthy donors. 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.

MTT with placebo + placebo supplementation.

Primary outcome measure

donor engraftment comparison [ Time Frame: week 12 ]

Central Contacts and Locations

Central contacts

Gretchen Peichel

gpeichel@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55414

More Information

Sponsor

University of Minnesota

Last update posted

Jul 31, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-07-31.