Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in PAH.

Conditions

• Pulmonary Arterial Hypertension

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• 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. — 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.

Study Details

This pilot clinical trial analysis 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.

Key Dates

First listed

Aug 7, 2026

Start date

Sep 1, 2026

Status verified

Aug 2026

Primary completion

Oct 31, 2029

Completion

Apr 30, 2030

Study Design

Enrollment

24 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

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.

Primary Outcome Measure

Donor engraftment comparison [ Time Frame: Week 12 ]

Central Contacts

• Gretchen Peichel
  6126266237
  [email protected]
• Thenappan Thenappan, MD
  6126261370
  [email protected]

Locations (1)

Find similar trials in Minneapolis, MN

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