NCT07490054 · Melana Yuzefpolskaya, MD
Intestinal Microbiota Transplantation in Patients With Chronic Heart Failure
(IMT)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
Where
- New York, New York
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 5, 2026 · Source of record for eligibility and locations