RecruitingPhase 1NCT07490054

Intestinal Microbiota Transplantation in Patients With Chronic Heart Failure

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

Enrollment

40 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

Chronic Heart Failure

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called MTP-101-C encapsulated Microbiota, a drug called Neomycin, and others for people with chronic heart failure. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALMTP-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.

DRUGVancomycin

glycopeptide antibiotic

DRUGNeomycin

aminoglycoside antibiotic