An Open-Label, Pilot Clinical Trial To Test The Safety And Feasibility Of Intestinal Microbiota Transplantation In Patients With Chronic Heart Failure
Melana Yuzefpolskaya, MD
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.
Description
Hypothesis: CHF is thought to be partly mediated by inflammation. The primary hypotheses are anchored in the premise that the pathophysiology of CHF is in part driven by inflammation arising from low diversity, dysbiotic intestinal microbiota through at least three mechanisms including: i) enrichment of gram- negative lipopolysaccharide (LPS) producers; ii) enrichment of organisms with uremic toxin producing potential, particularly in the setting of impaired renal functional which is common in CHF; iii) depletion of short chain fatty acid producers (SCFA) which are known to be important anti-i…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 *…
Interventions
- BiologicalMTP-101-C encapsulated Microbiota
Compound MTP-101-C was originally developed for treatment of the recurrent C. difficile infection syndrome (rCDI) following completion of anti-C. difficile antibiotic course. Fecal microbiota is prepared from stool of healthy human donors, who are screened and tested for infectious and non-infectious diseases. Raw stool is homogenized and filtered to separate the microbiota. The fecal microbiota is frozen in the presence of a lyoprotectant (trehalose), freeze-dried, and encapsulated into hypromellose capsules (DRcaps from Capsugel, Morristown, NJ). Each capsule contains ≥ 1 x 1011 and ≤ 2.0 x 1011 bacterial cells.
- DrugVancomycin
glycopeptide antibiotic
- DrugNeomycin
aminoglycoside antibiotic
Location
- Columbia University Irving Medical CenterNew York, New York