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Microbiota Therapy

Microbiota Transplant Therapy for Pulmonary Arterial Hypertension

Phase 1
Waitlist Available
Led By Daphne Moutsoglou, MD, PhD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial will test a new treatment for pulmonary arterial hypertension that involves transplanting intestinal microbiota from healthy donors. It will assess the safety and feasibility of this new treatment and also provide information to help develop future trials.

Eligible Conditions
  • Pulmonary Arterial Hypertension

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency of Serious Adverse Events
Proportion of IMT Compliance

Trial Design

1Treatment groups
Experimental Treatment
Group I: Microbiota Treatment ArmExperimental Treatment1 Intervention
Participants will receive the encapsulated microbiota intervention daily for seven days and will be subsequently monitored for six months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intestinal microbiota transplant (IMT)
2021
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,382 Previous Clinical Trials
1,551,298 Total Patients Enrolled
1 Trials studying Pulmonary Arterial Hypertension
2 Patients Enrolled for Pulmonary Arterial Hypertension
Daphne Moutsoglou, MD, PhDPrincipal InvestigatorUniversity of Minnesota Division of Gastroenterology
Thenappan Thenappan, MDPrincipal InvestigatorUniversity of Minnesota Division of Cardiology
2 Previous Clinical Trials
7 Total Patients Enrolled
1 Trials studying Pulmonary Arterial Hypertension
2 Patients Enrolled for Pulmonary Arterial Hypertension

Media Library

Intestinal microbiota transplant (IMT) (Microbiota Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04884971 — Phase 1
Pulmonary Arterial Hypertension Research Study Groups: Microbiota Treatment Arm
Pulmonary Arterial Hypertension Clinical Trial 2023: Intestinal microbiota transplant (IMT) Highlights & Side Effects. Trial Name: NCT04884971 — Phase 1
Intestinal microbiota transplant (IMT) (Microbiota Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04884971 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many volunteers have signed up to take part in this clinical trial?

"Affirmative. The details provided on clinicaltrials.gov indicate that this trial is actively trying to enrol participants, having been initially advertised November 3rd 2021 and last modified December 2nd 2021. 12 volunteers are needed at one centre for the study's conclusion."

Answered by AI

Does this clinical trial accommodate individuals aged sixty or above?

"The age range for this trial's participants is 18 to 75. The database on clinicaltrials.gov contains 54 studies that are suitable for minors and 662 studies specifically tailored towards seniors aged over 65 years old."

Answered by AI

Are there vacancies available for participants in this experimental program?

"Affirmative. Information on clinicaltrials.gov verifies that this investigation is currently enrolling patients, with an initial posting date of November 3rd 2021 and the most recent update occurring December 2nd 2021. 12 participants are being sought from a single medical facility."

Answered by AI

Is it possible to join the research cohort for this clinical trial?

"This clinical trial is currently accepting a dozen individuals aged between 18-75 years old with an active pulmonary arterial hypertension diagnosis. Furthermore, all participants must be able to ingest capsules, provide blood and fecal samples, as well as being in stable treatment for PAH one month prior to enrollment."

Answered by AI

Is Intestinal microbiota transplant (IMT) sanctioned by the FDA?

"Given the limited data surrounding efficacy and safety, our assessment of Intestinal microbiota transplant (IMT) is 1 on a scale from one to three."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Microbiota Transplant Therapy for Pulmonary Arterial Hypertension: Early Safety and Feasibility Study
2021. "Microbiota Transplant Therapy for Pulmonary Arterial Hypertension: Early Safety and Feasibility Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04884971.
~3 spots leftby May 2025
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