NCT07490054 Intestinal Microbiota Transplantation in Patients With Chronic Heart Failure
| NCT ID | NCT07490054 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Melana Yuzefpolskaya, MD |
| Condition | Chronic Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2025-09-01 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Melana Yuzefpolskaya, MD
PRINCIPAL INVESTIGATOR
Columbia University
Frequently Asked Questions
Who can join the NCT07490054 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07490054 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07490054 currently recruiting?
Yes, NCT07490054 is actively recruiting participants. Contact the research team at al4285@cumc.columbia.edu for enrollment information.
Where is the NCT07490054 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT07490054 clinical trial?
NCT07490054 is sponsored by Melana Yuzefpolskaya, MD. The principal investigator is Melana Yuzefpolskaya, MD at Columbia University. The trial plans to enroll 40 participants.
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