Restoring gut bacteria in adults 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
This trial tests whether replacing gut bacteria with healthy donor bacteria (intestinal microbiota transplantation) can reduce inflammation and improve function in adults with chronic heart failure.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Columbia University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation, methotrexate, prednisone |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT07490054 on ClinicalTrials.gov |
What this trial studies
This is a single-center, open-label Phase 1 study testing the safety and feasibility of intestinal microbiota transplantation (IMT) in adults with chronic heart failure (NYHA II–IV, HFrEF or HFpEF). Participants will receive seven days of oral antibiotic preconditioning (vancomycin and neomycin) followed by daily encapsulated donor microbiota (MTP-101-C) for seven days, with baseline and follow-up blood and stool sampling. Outcomes include changes in gut microbial diversity, systemic inflammatory markers, functional capacity (six-minute walk), and biomarkers of hemodynamic stress, with close safety monitoring. The protocol excludes patients with active inflammatory bowel disease, celiac disease, dialysis-dependent renal failure, recent transplant/LVAD listing, pregnancy, or pill-swallowing impairment.
Who should consider this trial
Good fit: Adults aged 18 or older with chronic heart failure (HFrEF or HFpEF), NYHA class II–IV, on stable heart-failure therapy for at least one month, able to swallow capsules and provide blood and stool samples, and willing to complete study visits and follow-up.
Not a fit: Patients with active inflammatory bowel disease, celiac disease, dialysis-dependent renal failure, anticipated transplant/LVAD placement within six months, pregnancy, or inability to swallow pills are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, IMT could lower gut-driven inflammation and improve exercise tolerance and biomarkers in people with chronic heart failure, potentially improving symptoms and quality of life.
How similar studies have performed: IMT is an established, effective treatment for recurrent C. difficile infection and has shown preliminary signals in metabolic and inflammatory conditions, but its use specifically for chronic heart failure is novel and unproven.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York
- Columbia University Irving Medical Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Melana Yuzefpolskaya, MD — Columbia University
- Study coordinator: Annamaria Ladanyi, MD
- Email: al4285@cumc.columbia.edu
- Phone: 2123426058
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.