Healthy donor gut bacteria capsules for people with chronic heart failure
Tests donor gut bacteria capsules for safety in adults with chronic heart failure.
Plain-language title generated from the registry record
Registry title: Intestinal Microbiota Transplantation in Patients With Chronic Heart Failure
Key facts
- Where
- New York, United StatesSee the site
- Phase
- Phase 1
Where in United States
- Columbia University Irving Medical CenterNew York, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Melana Yuzefpolskaya, MD
- Trial code
- NCT07490054
- Record updated
- 8 October 2026
- Original 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.Read full original descriptionShow less
An Open-Label, Pilot Clinical Trial To Test The Safety And Feasibility Of Intestinal Microbiota Transplantation In Patients With Chronic Heart Failure
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.
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: 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; 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; Patients with neutropenia (an absolute neutrophil count < 0.5 x 109 cells/L) obtained on a complete blood count with differential at screening; Dysphagia to pills; Acute myocarditis; Infiltrative and hypertrophic cardiomyopathies; Life expectancy of < 6 months; Presence of ileostomy or colostomy.