NCT07490054RecruitingPhase 1

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

Source: ClinicalTrials.gov · Last updated 8 Oct 2026

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Phase (registry): Phase 1
Study type: Interventional
Enrollment: 40 (estimated)
First submitted: 18 Mar 2026
Start date: 20 Oct 2025
Primary completion date: Sept 2027
Lead sponsor: Melana Yuzefpolskaya, MD
Diseases: Heart failure
NCT number: NCT07490054

What you commit to

Study type: Interventional · Phase 1
Planned participants: 40
From 20 Oct 2025 to the primary completion date, Sept 2027
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Listed for transplant, and anticipated transplant listing or LVAD placement in the next 6 months
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.
Patients on immunosuppressants (calcineurin inhibitors, prednisone ≥ 20 mg/day, methotrexate, azathioprine, immunosuppressive biologics, JAK inhibitors).
Patients receiving cancer chemotherapy, immunotherapy, or radiation

Other illness

Clinically active inflammatory bowel disease
History of celiac disease
Renal disease requiring dialysis
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

Lab values

Patients with neutropenia (an absolute neutrophil count \< 0.5 x 109 cells/L) obtained on a complete blood count with differential at screening

Other

Dysphagia to pills
Acute myocarditis
Infiltrative and hypertrophic cardiomyopathies
Life expectancy of \< 6 months
Presence of ileostomy or colostomy

Who the study is looking for

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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Columbia University Irving Medical Center Coordinator of this site? Confirm its status	New York	United States	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.