Intestinal Microbiota Transplantation for Chronic Heart Failure

(IMT Trial)

Overseen By Annamaria Ladanyi, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Melana Yuzefpolskaya, MD

Must not be taking: Immunosuppressants, Chemotherapy

Disqualifiers: Inflammatory bowel disease, Celiac, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

Melana Yuzefpolskaya, MD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

Inclusion Criteria

I am able to swallow capsules.

I am able to give both blood and stool samples.

I have been on the same heart failure treatment for at least one month.

Exclusion Criteria

Dysphagia to pills

I currently have active inflammatory bowel disease.

I have been diagnosed with celiac disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Antibiotic Preconditioning

Participants receive antibiotic preconditioning with Vancomycin and Neomycin for 7 days

1 week

1 visit (in-person)

IMT Treatment

Participants receive Intestinal Microbiota Transplantation (IMT) daily for 7 days

1 week

Daily visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up visits or surveys on days 1-21 and monthly up to 6 months post-IMT

6 months

Multiple visits (in-person, virtual, or survey)

What Are the Treatments Tested in This Trial?

Interventions

• Intestinal Microbiota Transplantation

How Is the Trial Designed?

Group I: Participants with Chronic Heart Failure (CHF) Experimental Treatment 3 Interventions

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.

Who Is Running the Clinical Trial?

Melana Yuzefpolskaya, MD

Lead Sponsor