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Intestinal Microbiota Transplantation for Chronic Heart Failure

This study is looking at whether replacing gut bacteria with healthy donor bacteria, called Intestinal Microbiota Transplantation (IMT), can help people with chronic heart failure (CHF). People with CHF often have different gut bacteria than healthy individuals. IMT uses MTP-101-C, which is prepared from healthy donor stool. Before receiving IMT, you would take antibiotics called Vancomycin and Neomycin. Researchers believe that unhealthy gut bacteria might contribute to inflammation in CHF. This study aims to see if IMT can improve gut health, reduce inflammation, and improve your overall well-being. The study plans to enroll 40 participants aged 18 and older who have been diagnosed with CHF and are on stable treatment. The main goals are to track any side effects and how well participants take the study medication.

Study design
This is a Phase 1, single-center study that is open-label, meaning both you and the study team will know what treatment you are receiving. It plans to enroll 40 participants.
What's involved
You would take antibiotics for 7 days, followed by IMT daily for an additional 7 days. You would also need to provide blood and fecal samples.
Compensation
Not stated in the trial record.
Follow-up
The study will track adverse events for 180 days after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07490054

Intestinal Microbiota Transplantation in Patients With Chronic Heart Failure

Recruiting
PHASE1Ages 18+InterventionalTreatment
Melana Yuzefpolskaya, MD
~40 participants
Updated 2026-05-05 on ClinicalTrials.gov
What's tested:MTP-101-C encapsulated MicrobiotaVancomycinNeomycin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Adverse Events
Measured over Day 180
+1 more outcome measured

Conditions

Chronic Heart Failure

Explore related trials

Heart failure with normal ejection fractionHeart failure with reduced ejection fraction

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Melana Yuzefpolskaya, MD · PRINCIPAL_INVESTIGATOR · Columbia University

Who to contact

Annamaria Ladanyi, MD
[email protected]
2123426058
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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

What this trial measures

  • Number of Adverse EventsDay 180

    Safety will be measured by the number of adverse events that occur in participants.

  • Study Drug AdherenceDay 14

    Study drug adherence (compliance) will be measured as the number of participants taking 100% (all doses) of the IMT.