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Studies

Interventional Recruiting Phase 1

NCT07490054 on ClinicalTrials.gov

Intestinal Microbiota Transplantation in Patients With Chronic Heart Failure

Official title: 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 (Estimated)
  • Study start: 2025-10-20 (Actual)
  • Primary completion: 2027-09-01 (Estimated)
  • Study completion: 2027-11-01 (Estimated)
  • Allocation: N/a
  • InterventionModel: Single Group
  • Masking: None
  • PrimaryPurpose: Treatment

Brief 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.

Conditions

  • Chronic Heart Failure

Intervention / Treatment

  • Biological: MTP-101-C encapsulated Microbiota
  • Drug: Vancomycin
  • Drug: Neomycin

Primary Outcome Measures

  • Number of Adverse Events (Day 180)
    Safety will be measured by the number of adverse events that occur in participants.
  • Study Drug Adherence (Day 14)
    Study drug adherence (compliance) will be measured as the number of participants taking 100% (all doses) of the IMT.

Countries

United States

Locations and Investigators

  • Columbia University Irving Medical Center, New York, United States (Recruiting)
    • Annamaria Ladanyi, MD
    • Melana Yuzefpolskaya, MD (Principal Investigator)
    • Paolo Colombo, MD
    • Ryan Demmer, PhD (Principal Investigator)

Study Officials