Intestinal Microbiota Transplantation in Patients With Chronic Heart Failure

Part of paid clinical trials in New York, New York.

Sponsor
Melana Yuzefpolskaya, MD
Study ID
NCT07490054
Phase
PHASE1
Status
Recruiting
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Conditions

  • Chronic Heart Failure

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MTP-101-C encapsulated Microbiota — BIOLOGICAL
    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

Study Details

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.

Key Dates

Start date
Sep 1, 2025
Status verified
Apr 2026
Primary completion
Sep 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Participants with Chronic Heart Failure (CHF)
    Antibiotic preconditioning: The antibiotic conditioning regimen will occur in the 7 days prior to IMT therapy. Antibiotic conditioning will consist of 250 mg of Vancomycin twice daily for 7 days + 500 mg of Neomycin twice daily for 7 days. IMT dosing: A single dose consists of four, size 00 capsules of MTP-101C. An individual study participant will take the drug from a single lot only. Each lot contains microbiota separated and prepared from the stool of the individual donor and includes the dates of donation. Each dose (four capsules) will be taken daily in the morning on an empty stomach. Clear liquids are allowed, and a regular breakfast can follow two hours later. Alternatively, the capsules can be taken after four hours of clear liquids, and no food other than clear liquids are allowed for two hours after the capsules are taken. The IMT treatment is administered for seven days. However, if the patient is hospitalized or wishes to stop the treatment, it will be stopped.

Primary Outcome Measure

Number of Adverse Events [ Time Frame: Day 180 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Irving Medical CenterNew YorkNew York10032
Annamaria Ladanyi, MD
[email protected]
212-342-6058
Melana Yuzefpolskaya, MD (PRINCIPAL_INVESTIGATOR)
Paolo Colombo, MD (SUB_INVESTIGATOR)
Ryan Demmer, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By research site
Columbia University Irving Medical Center· New York, NY

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