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NCT Number: NCT06481852

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

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.

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Key information

Conditions

Pulmonary Arterial Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location status: Recruiting

Location contact

Gretchen Peichel

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MTT with antibiotic preconditioning + fiber supplementation

Drug

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

Drug

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.

Other

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.

Primary outcomes

  1. donor engraftment comparison

    Time frame: week 12

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

Secondary outcomes

  1. safety of MTT with antibiotic preconditioning and fiber supplementation in patients with PAH

    Time frame: week 12

    The difference in frequency of serious adverse events and other adverse events between the three study groups

  2. feasibility of MTT with antibiotic preconditioning and fiber supplementation in patients with PAH

    Time frame: week 12

    The differences in proportion of subjects taking 100% of the MTT per protocol between the three study groups

  3. change in inflammatory markers

    Time frame: week 12

    The differences in the change in circulating markers of inflammation and microbial metabolites from baseline to week 12 between the three study groups

  4. compare right ventricular function, measure 1

    Time frame: week 12

    The differences in the change in six-minute walk distance (6MWD) from baseline to week 12 between the three study groups

  5. compare right ventricular function

    Time frame: week 12

    The differences in the change in right ventricular ejection fraction from baseline to week 12 between the three study groups

  6. compare right ventricular function

    Time frame: week 12

    The differences in the change in quality of life survey from baseline to week 12 between the three study groups

Study contacts

Contact information is provided by the study sponsor or research team.

Gretchen Peichel

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jul 1, 2024
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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