Actively Recruiting
Intestinal Microbiota Transplantation in Patients With Chronic Heart Failure
Led by Melana Yuzefpolskaya, MD · Updated on 2026-05-05
40
Participants Needed
1
Research Sites
113 weeks
Total Duration
On this page
AI-Summary
What this Trial 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. 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.
CONDITIONS
Official Title
Intestinal Microbiota Transplantation in Patients With Chronic Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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
- 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 10^9 cells/L)
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
Research Team
A
Annamaria Ladanyi, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here