Status:
COMPLETED
Microbiota Transplant Therapy for Pulmonary Arterial Hypertension: Early Safety and Feasibility Study
Lead Sponsor:
University of Minnesota
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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...
Detailed Description
Pulmonary arterial hypertension (PAH) is a chronic disease characterized by pulmonary vascular remodeling of precapillary pulmonary arteries resulting in obstruction, increased pulmonary vascular resi...
Eligibility Criteria
Inclusion
- Diagnosis of pulmonary arterial hypertension (PAH)
- On stable treatment for PAH for one month prior to enrollment
- Able to swallow capsultes
- Able to provide blood sample and fecal sample
Exclusion
- Dysphagia to pills
- Clinically active inflammatory bowel disease
- Pregnancy or breastfeeding
- Life expectancy of \<6 months
- Presence of ileostomy or colostomy
- Taking immunosuppressants (calcineurin inhibitors, prednisone greater than or equal to 20mg/day, methotrexate, azathioprine, immunosuppressive biologics, JAK inhibitors)
- Neurotropenia (an absolute neurotrophil count \< 0.5 x 10\^9 cells/L)
- History of solid organ or bone marrow transplant
- Anticipated recurrent antibiotic use (participants with frequent urinary tract infections or sinusitis)
- History of severe anaphylactic food allergy
- History of celiac disease
- History of receiving cancer chemotherapy, immunotherapy, or radiation
Key Trial Info
Start Date :
November 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04884971
Start Date
November 3 2021
End Date
December 31 2023
Last Update
February 12 2024
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455