Microbiota Transplant Therapy for Pulmonary Arterial Hypertension: Early Safety and Feasibility Study

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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 development of future trials in treatment of PAH. Active drug in capsule form composed of freeze-dried, encapsulated intestinal microbiota from healthy donors will be administered to patients with PAH. This study will also allow for limited evaluation of pharmacokinetics in terms of donor microbiota engraftment and pharmacodynamics in terms of potential mechanisms. It will also allow for limited evaluation of cardiac endurance and function prior to and after IMT.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Minnesota

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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