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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

MTP-101-C encapsulated Microbiota
Biological/Vaccine
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.
Vancomycin
Drug
glycopeptide antibiotic
Neomycin
Drug
aminoglycoside antibiotic

Treatment groups

40 Participants

are divided into 1 treatment group

Group A: Participants with Chronic Heart Failure (CHF)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

Number of Adverse Events

Safety will be measured by the number of adverse events that occur in participants.

Time frame

Day 180

Study Drug Adherence

Study drug adherence (compliance) will be measured as the number of participants taking 100% (all doses) of the IMT.

Time frame

Day 14

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Melana Yuzefpolskaya, MD

Lead sponsor

Columbia University

Sponsor institution

Source ClinicalTrials.gov

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