Restoring gut bacteria in adults with chronic heart failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.