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

NCT04884971 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2024-02-12

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Intestinal microbiota transplant (IMT)

Two size 00 capsules from a single lot will be taken daily. Approximately 2.0 x 10\^11 bacteria from a healthy donor are contained in each capsule.

Sponsors & Collaborators

Principal Investigators

  • Thenappan Thenappan, MD · University of Minnesota Division of Cardiology

  • Kurt Prins, MD, PhD · University of Minnesota Division of Cardiology

  • Edward Weir, MD · University of Minnesota Division of Cardiology

  • Alexander Khoruts, MD · University of Minnesota Division of Gastroenterology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-03
Primary Completion
2023-12-31
Completion
2023-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04884971 on ClinicalTrials.gov