Recruiting
Phase 1

Intestinal Microbiota Transplantation

Sponsor:

Melana Yuzefpolskaya, MD

Code:

NCT07490054

Conditions

Chronic Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MTP-101-C encapsulated Microbiota

Vancomycin

Neomycin

Study Details

Brief 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.

Conditions

Chronic Heart Failure

Study ID

NCT07490054

Start date

Sep 1, 2025

Status verified date

Apr, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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
  • 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. A pregnancy test will be obtained from females of child-bearing potential at the screening visit or day 1 (prior to the receipt of IMT). Patients with a positive pregnancy test will be excluded. A negative result will be required for subjects who are females of child-bearing potential to receive IMT treatment. Patients will be counseled to avoid pregnancy which is the standard of care for patients with CHF.
  • 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 109 cells/L) obtained on a complete blood count with differential at screening
  • 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

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

MTP-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.

Vancomycin

glycopeptide antibiotic

Neomycin

aminoglycoside antibiotic

Primary outcome measure

  • Number of Adverse Events [ Time Frame: Day 180 ]
  • Study Drug Adherence [ Time Frame: Day 14 ]

Central Contacts and Locations

Central contacts

Annamaria Ladanyi, MD

2123426058al4285@cumc.columbia.edu

Locations

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Annamaria Ladanyi, MD

212-342-6058al4285@cumc.columbia.edu

Principal Investigator:

Melana Yuzefpolskaya, MD

More Information

Sponsor

Melana Yuzefpolskaya, MD

Last update posted

May 5, 2026

Last verified

Apr, 2026

Keywords

  • Heart Failure
  • Intestinal Microbiota Transplantation
  • Heart Failure with Reduced Ejection Fraction
  • Heart Failure with Preserved Ejection Fraction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Melana Yuzefpolskaya, MD on 2026-05-05.