Phase 1Recruiting
Intestinal Microbiota Transplantation in Patients With Chronic Heart Failure (IMT)
An Open-Label, Pilot Clinical Trial To Test The Safety And Feasibility Of Intestinal Microbiota Transplantation In Patients With Chronic Heart Failure
- Sponsor
- Melana Yuzefpolskaya, MD (Academic or other)
- Enrollment
- 40 planned
- Conditions
- Chronic Heart Failure
- Interventions
- MTP-101-C encapsulated Microbiota; Vancomycin; Neomycin
- Ages
- adults, older adults
- Registry
- NCT07490054
Full record on ClinicalTrials.gov
From the registry
The purpose of this study is to determine whether people with CHF, who often have different gut bacteria from healthy, would benefit from replacing their gut bacteria with healthy donor bacteria (also known as Intestinal Microbiota Transplantation - IMT). IMT aims to restore healthy gut bacteria in patients with CHF, with previous studies showing its effectiveness, but further research is needed. IMT is an approved treatment for patients with infectious diarrhea. More than 10,000 IMTs are performed every year in the US. However IMT is not approved for patients with CHF, and thus considered investigational.
Primary outcomes
- Number of Adverse Events
- Study Drug Adherence
History
Study completion expected
Primary completion expected
Last registry update
Registered
Started