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

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.

Timeline

Start

2021-11-03

Primary completion

2023-12-31

Completion

2023-12-31

Publications

• Moutsoglou D, Blake M, Belhasan DC, Peichel G, Vang BM, Weir EK, Lopez S, Prins KW, Kabage AJ, Prisco SZ, Kremer BP, Khoruts A, Thenappan T. Microbiota Transplant Therapy Is Safe and Feasible in Pulmonary Arterial Hypertension. JACC Basic Transl Sci. 2025 Sep;10(9):101347. doi: 10.1016/j.jacbts.2025.101347. Epub 2025 Aug 12.

Drugs

Indications