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Clinical Trial NCT07490054 (IMT) for Chronic Heart Failure is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Intestinal Microbiota Transplantation in Patients With Chronic Heart Failure (IMT) Phase 1 40

Recruiting
Clinical Trial NCT07490054 (IMT) is designed to study Treatment for Chronic Heart Failure. It is a Phase 1 interventional study that is recruiting, having started on 1 September 2025, with plans to enroll 40 participants. Led by Melana Yuzefpolskaya, MD, it is expected to complete by 1 November 2026. The latest data from ClinicalTrials.gov was last updated on 24 March 2026.
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 t...Show More
Detailed Description
Hypothesis: CHF is thought to be partly mediated by inflammation. The primary hypotheses are anchored in the premise that the pathophysiology of CHF is in part driven by inflammation arising from low diversity, dysbiotic intestinal microbiota through at least three mechanisms including: i) enrichment of gram- negative lipopolysaccharide (LPS) producers; ii) enrichment of organisms with uremic toxin producing potentia...Show More
Official Title

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

Conditions
Chronic Heart Failure
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • IMT
  • AAAV0014
NCT ID Number
NCT07490054
Start Date (Actual)
2025-09-01
Last Update Posted
2026-03-24
Completion Date (Estimated)
2026-11
Enrollment (Estimated)
40
Study Type
Interventional
PHASE
Phase 1
Status
Recruiting
Keywords
Heart Failure
Intestinal Microbiota Transplantation
Heart Failure with Reduced Ejection Fraction
Heart Failure with Preserved Ejection Fraction
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalParticipants with Chronic Heart Failure (CHF)
Antibiotic preconditioning: The antibiotic conditioning regimen will occur in the 7 days prior to IMT therapy. Antibiotic conditioning will consist of 250 mg of Vancomycin twice daily for 7 days + 500 mg of Neomycin twice daily for 7 days. IMT dosing: A single dose consists of four, size 00 capsules of MTP-101C. An individual study participant will take the drug from a single lot only. Each lot contains microbiota s...Show More
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 pres...Show More
Vancomycin
glycopeptide antibiotic
Neomycin
aminoglycoside antibiotic
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Number of Adverse Events
Safety will be measured by the number of adverse events that occur in participants.
Day 180
Study Drug Adherence
Study drug adherence (compliance) will be measured as the number of participants taking 100% (all doses) of the IMT.
Day 14
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • Diagnosis of Heart Failure with Reduced Ejection Fraction (HFrEF) or Heart Failure with Reduced Ejection Fraction (HFpEF), New York Heart Association Class II-IV
  • On stable treatment for CHF for one month prior to enrollment
  • Able to swallow capsules
  • Able to provide blood sample and fecal sample
  • Stated willingness to comply with all study procedures and availability for the duration of trial to follow-up by telephone, in-person, email, and/or video visits or correspondence.

  • Dysphagia to pills
  • Clinically active inflammatory bowel disease
  • History of celiac disease
  • Listed for transplant, and anticipated transplant listing or LVAD placement in the next 6 months
  • Acute myocarditis
  • Infiltrative and hypertrophic cardiomyopathies
  • Renal disease requiring dialysis
  • Pregnancy or breastfeeding. A pregnancy test will be obtained from females of child-bearing potential at the screening visit or day 1 (prior to the receipt of IMT). Patients with a positive pregnancy test will be excluded. A negative result will be required for subjects who are females of child-bearing potential to receive IMT treatment. Patients will be counseled to avoid pregnancy which is the standard of care for patients with CHF.
  • Life expectancy of < 6 months
  • Presence of ileostomy or colostomy
  • Patients on immunosuppressants (calcineurin inhibitors, prednisone ≥ 20 mg/day, methotrexate, azathioprine, immunosuppressive biologics, JAK inhibitors).
  • Patients with neutropenia (an absolute neutrophil count < 0.5 x 109 cells/L) obtained on a complete blood count with differential at screening
  • History of solid organ or bone marrow transplant
  • Anticipated recurrent antibiotic use (patients with frequent urinary tract infections or sinusitis)
  • History of severe anaphylactic food allergy
  • Patients receiving cancer chemotherapy, immunotherapy, or radiation
Melana Yuzefpolskaya, MD logoMelana Yuzefpolskaya, MD
Study Responsible Party
Melana Yuzefpolskaya, MD, Sponsor-Investigator, Associate Professor of Medicine, Columbia University
Study Central Contact
Contact: Annamaria Ladanyi, MD, 2123426058, [email protected]
1 Study Locations in 1 Countries

New York

Columbia University Irving Medical Center, New York, New York, 10032, United States
Annamaria Ladanyi, MD, Contact, 212-342-6058, [email protected]
Melana Yuzefpolskaya, MD, Principal Investigator
Paolo Colombo, MD, Sub-Investigator
Ryan Demmer, PhD, Principal Investigator
Recruiting