Intestinal Microbiota Transplantation in Patients With Chronic Heart Failure
ConditionChronic Heart Failure
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMelana Yuzefpolskaya, MD
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- MTP-101-C encapsulated Microbiota
- Vancomycin
- Neomycin
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
Melana Yuzefpolskaya, MD
Lead sponsor
Columbia University
Sponsor institution
Source ClinicalTrials.gov