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Microbiota Therapy

Microbiota Transplant Therapy for Pulmonary Hypertension

Phase 1
Recruiting
Led By Alexander Khoruts, MD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Ages 18-75
* Able to swallow capsules
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12

Summary

This trial will test the safety and effectiveness of a treatment called microbiota transplant therapy (MTT) in patients with pulmonary arterial hypertension (PAH). Patients will receive capsules containing healthy intestinal bacteria, along

Who is the study for?
This trial is for adults aged 18-75 with pulmonary arterial hypertension (PAH) who have been on stable PAH treatment for at least a month. Participants must be able to swallow capsules, provide blood and stool samples, and commit to the study's schedule including follow-ups.
What is being tested?
The trial tests microbiota transplant therapy (MTT) with antibiotic preconditioning and fiber supplementation versus placebo in PAH patients. It aims to assess safety, feasibility, and how the body processes MTT. Patients are randomly assigned to one of three groups: MTT plus fiber, MTT plus placebo fiber or double placebo.
What are the potential side effects?
Potential side effects may include digestive discomfort due to antibiotics or fiber supplements, reactions from the microbiota capsules such as bloating or gas, and any unforeseen effects related to altering gut bacteria.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 75 years old.
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I can swallow pills.
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I have been diagnosed with pulmonary arterial hypertension (PAH).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
donor engraftment comparison
Secondary study objectives
change in inflammatory markers
compare right ventricular function
compare right ventricular function, measure 1
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Drug groupExperimental Treatment1 Intervention
PAH patients randomized to MTT with antibiotic preconditioning + fiber supplementation
Group II: Control 1Active Control1 Intervention
MTT with antibiotic preconditioning + placebo supplementation
Group III: Control 2Placebo Group1 Intervention
placebo + placebo supplementation.

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,434 Previous Clinical Trials
1,621,678 Total Patients Enrolled
2 Trials studying Pulmonary Arterial Hypertension
13 Patients Enrolled for Pulmonary Arterial Hypertension
Alexander Khoruts, MDPrincipal InvestigatorUniversity of Minnesota
3 Previous Clinical Trials
53 Total Patients Enrolled
1 Trials studying Pulmonary Arterial Hypertension
11 Patients Enrolled for Pulmonary Arterial Hypertension
Christopher Staley, PhDPrincipal InvestigatorUniversity of Minnesota
~16 spots leftby Sep 2026
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