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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
Recruiting
There is evidence that the gut microbes interact with the body’s immune system, and people with pulmonary hypertension may have altered composition of gut microbes. We are studying whether transplanting gut microbes from healthy donors using a treatment called microbiota transplant therapy may have beneficial effects on pulmonary arterial hypertension.
Male or Female
18 years and over
Inclusion Criteria:
• ages 18-75
• diagnosis of pulmonary arterial hypertension (PAH)
• on stable treatment for PAH for one month prior to enrollment
• able to swallow capsules
• able to provide blood sample and fecal sample
Exclusion Criteria:
• active inflammatory bowel disease or celiac disease
• women who are pregnant or breastfeeding
• presence of ileostomy or colostomy
• on immunosuppressants (calcineurin inhibitors, prednisone at a dose of 20 mg/day or more, methotrexate, azathioprine, immunosuppressive biologics, JAK inhibitors).
• history of solid organ or bone marrow transplant
• anticipated recurrent antibiotic use (patients with frequent urinary tract infections or sinusitis)
• history of severe anaphylactic food allergy
• receiving cancer chemotherapy, immunotherapy, or radiation
Drug: MTT with antibiotic preconditioning + fiber supplementation, Drug: MTT with antibiotic preconditioning + placebo supplementation, Other: MTT with placebo + placebo supplementation.
Heart & Vascular, Microbiota
Microbiota transplant therapy, PAH, pulmonary arterial hypertension, Clinics and Surgery Center (CSC), gut
Gretchen Peichel - gpeichel@umn.edu
Thenappan Thenappan
PHASE1
STUDY00022382
See this study on ClinicalTrials.gov