Intestinal Microbiota Transplantation in Patients With Chronic Heart Failure

NCT07490054 | Recruiting Phase 1 FDA Drug

• 1 other identifier: AAAV0014
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Heart Failure; Intestinal Microbiota Transplantation; Heart Failure with Reduced Ejection Fraction; Heart Failure with Preserved Ejection Fraction

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Participants with Chronic Heart Failure (CHF)

EXPERIMENTAL

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 separated and prepared from the stool of the individual donor and includes the dates of donation. Each dose (four capsules) will be taken daily in the morning on an empty stomach. Clear liquids are allowed, and a regular breakfast can follow two hours later. Alternatively, the capsules can be taken after four hours of clear liquids, and no food other than clear liquids are allowed for two hours after the capsules are taken. The IMT treatment is administered for seven days. However, if the patient is hospitalized or wishes to stop the treatment, it will be stopped.

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

Interventions

MTP-101-C encapsulated Microbiota BIOLOGICAL

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.

Also known as: MTP-101-C

Participants with Chronic Heart Failure (CHF)

Vancomycin DRUG

glycopeptide antibiotic

Participants with Chronic Heart Failure (CHF)

Neomycin DRUG

aminoglycoside antibiotic

Participants with Chronic Heart Failure (CHF)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Melana Yuzefpolskaya, MD: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

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MeSH Terms

Conditions

Heart Failure

Interventions

Vancomycin; Neomycin

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Aminoglycosides; Glycosides

Study Officials

• Melana Yuzefpolskaya, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annamaria Ladanyi, MD

CONTACT

2123426058; al4285@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 24, 2026
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)