RECRUITING

A Placebo-controlled, Randomized Clinical Trial to Assess the Safety, Feasibility, and Pharmacokinetics of Microbiota Transplant Therapy With Antibiotic Preconditioning and Fiber Supplementation in Patients With Pulmonary Arterial Hypertension

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Conditions

Pulmonary Arterial Hypertension

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This pilot clinical trial 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.

Official Title

A Placebo-controlled, Randomized Clinical Trial to Assess the Safety, Feasibility, and Pharmacokinetics of Microbiota Transplant Therapy With Antibiotic Preconditioning and Fiber Supplementation in Patients With Pulmonary Arterial Hypertension

Quick Facts

Study Start:2024-09-01
Study Completion:2026-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06481852

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Provision of signed and dated consent form
  2. * Ages 18-75
  3. * Diagnosis of PAH
  4. * On stable treatment for PAH for one month prior to enrollment
  5. * Able to swallow capsules
  6. * Able to provide blood sample and fecal sample
  7. * Stated willingness to comply with all study procedures and availability for the duration of trial to follow-up by telephone, in-person, email, and/or video visits or correspondence.
  1. * Dysphagia to pills
  2. * Clinically active inflammatory bowel disease
  3. * Pregnancy or breastfeeding. A pregnancy test will be obtained from females of child- bearing potential at the screening visit or day 1 (prior to the receipt of MTT). Patients with a positive pregnancy test will be excluded. A negative result will be required for subjects who are females of child-bearing potential to receive MTT. Patients will be counseled to avoid pregnancy which is the standard of care for patients with PAH.
  4. * Life expectancy of \< 6 months
  5. * Presence of ileostomy or colostomy
  6. * Patients on immunosuppressants (calcineurin inhibitors, prednisone ≥ 20 mg/day, methotrexate, azathioprine, immunosuppressive biologics, JAK inhibitors).
  7. * Patients with neutropenia (an absolute neutrophil count \< 0.5 x 10 9 cells/L) obtained on a complete blood count with differential at screening
  8. * History of solid organ or bone marrow transplant
  9. * Anticipated recurrent antibiotic use (patients with frequent urinary tract infections or sinusitis)
  10. * History of severe anaphylactic food allergy
  11. * History of celiac disease
  12. * Patients receiving cancer chemotherapy, immunotherapy, or radiation

Contacts and Locations

Study Contact

Gretchen Peichel
CONTACT
gpeichel@umn.edu

Principal Investigator

Thenappan Thenappan, MD
PRINCIPAL_INVESTIGATOR
University of Minnesota
Levi Teigen, MD, PhD
PRINCIPAL_INVESTIGATOR
University of Minnesota
Alexander Khoruts, MD
PRINCIPAL_INVESTIGATOR
University of Minnesota
Christopher Staley, PhD
PRINCIPAL_INVESTIGATOR
University of Minnesota
Kurt Prins, MD,PhD
PRINCIPAL_INVESTIGATOR
University of Minnesota
Edward Weirs, MD
PRINCIPAL_INVESTIGATOR
University of Minnesota

Study Locations (Sites)

University of Minnesota
Minneapolis, Minnesota, 55414
United States

Collaborators and Investigators

Sponsor: University of Minnesota

  • Thenappan Thenappan, MD, PRINCIPAL_INVESTIGATOR, University of Minnesota
  • Levi Teigen, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Minnesota
  • Alexander Khoruts, MD, PRINCIPAL_INVESTIGATOR, University of Minnesota
  • Christopher Staley, PhD, PRINCIPAL_INVESTIGATOR, University of Minnesota
  • Kurt Prins, MD,PhD, PRINCIPAL_INVESTIGATOR, University of Minnesota
  • Edward Weirs, MD, PRINCIPAL_INVESTIGATOR, University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-01
Study Completion Date2026-09-01

Study Record Updates

Study Start Date2024-09-01
Study Completion Date2026-09-01

Terms related to this study

Additional Relevant MeSH Terms

  • Pulmonary Arterial Hypertension