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RECRUITING
NCT07490054
PHASE1

Intestinal Microbiota Transplantation in Patients With Chronic Heart Failure

Sponsor: Melana Yuzefpolskaya, MD

View on ClinicalTrials.gov

Summary

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.

Official title: An Open-Label, Pilot Clinical Trial To Test The Safety And Feasibility Of Intestinal Microbiota Transplantation In Patients With Chronic Heart Failure

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-09-01

Completion Date

2026-11

Last Updated

2026-03-24

Healthy Volunteers

No

Interventions

BIOLOGICAL

MTP-101-C encapsulated Microbiota

Compound MTP-101-C was originally developed for treatment of the recurrent C. difficile infection syndrome (rCDI) following completion of anti-C. difficile antibiotic course. Fecal microbiota is prepared from stool of healthy human donors, who are screened and tested for infectious and non-infectious diseases. Raw stool is homogenized and filtered to separate the microbiota. The fecal microbiota is frozen in the presence of a lyoprotectant (trehalose), freeze-dried, and encapsulated into hypromellose capsules (DRcaps from Capsugel, Morristown, NJ). Each capsule contains ≥ 1 x 1011 and ≤ 2.0 x 1011 bacterial cells.

DRUG

Vancomycin

glycopeptide antibiotic

DRUG

Neomycin

aminoglycoside antibiotic

Locations (1)

Columbia University Irving Medical Center

New York, New York, United States