Clinical trialNCT04884971CompletedPhase 1Interventional

Microbiota Transplant Therapy for Pulmonary Arterial Hypertension: Early Safety and Feasibility Study

SponsorUniversity of MinnesotaEnrollment11Pulmonary Arterial Hypertension

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This pilot clinical trial will evaluate the initial safety and feasibility of intestinal microbiota transplantation (IMT) in patients with pulmonary arterial hypertension (PAH). This trial will inform development of future trials in treatment of PAH. Active drug in capsule form composed of freeze-dried, encapsulated intestinal microbiota from healthy donors will be administered to patients with PAH. This study will also allow for limited evaluation of pharmacokinetics in terms of donor microbiota engraftment and pharmacodynamics in terms of potential mechanisms. It will also allow for limited evaluation of cardiac endurance and function prior to and after IMT.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Alexander Khoruts, MD
University of Minnesota Division of Gastroenterology
Principal Investigator
clinicaltrials.gov ↗
Edward Weir, MD
University of Minnesota Division of Cardiology
Principal Investigator
clinicaltrials.gov ↗
Kurt Prins, MD, PhD
University of Minnesota Division of Cardiology
Principal Investigator
clinicaltrials.gov ↗
Thenappan Thenappan, MD
University of Minnesota Division of Cardiology
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of Minnesota
Minneapolis, Minnesota, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Intestinal microbiota transplant

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 3 Nov 2021
Primary completion: 31 Dec 2023
Completion: 31 Dec 2023
Last update posted: 12 Feb 2024
Registered enrollment: 11
Registry id: NCT04884971

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.