Intestinal Microbiota Transplantation for Chronic Heart Failure
(IMT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether replacing gut bacteria with healthy donor bacteria can benefit individuals with chronic heart failure. The aim is to determine if Intestinal Microbiota Transplantation (IMT) can enhance heart health by restoring healthy gut bacteria. While already used for severe diarrhea, this treatment remains experimental for heart failure. Participants must have managed their heart failure with stable treatment for at least a month and be comfortable swallowing capsules. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this innovative treatment.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, you must be on stable treatment for heart failure for one month before joining the study.
What prior data suggests that Intestinal Microbiota Transplantation is safe for patients with Chronic Heart Failure?
Research has shown that Intestinal Microbiota Transplantation (IMT) is usually well-tolerated. Studies have found that most side effects, such as stomach upset, are mild to moderate and rarely lead to discontinuation of treatment. In the U.S., more than 10,000 IMT procedures are performed annually for conditions like infectious diarrhea, where it is already approved. This indicates that the treatment is relatively safe, although it remains under study for chronic heart failure.12345
Why do researchers think this study treatment might be promising for heart failure?
Unlike the standard treatments for chronic heart failure, which typically include medications like ACE inhibitors, beta-blockers, and diuretics, Intestinal Microbiota Transplantation (IMT) offers a novel approach by targeting the gut microbiome. Researchers are excited about IMT because it harnesses beneficial bacteria from healthy donors to potentially improve heart function and overall health. This innovative method could provide a new pathway for treatment by addressing the underlying gut-heart connection, offering hope for more personalized and effective management of chronic heart failure.
What evidence suggests that Intestinal Microbiota Transplantation might be an effective treatment for chronic heart failure?
Research has shown that people with chronic heart failure (CHF) often have different gut bacteria compared to healthy individuals, and this imbalance might affect heart health. This trial will explore the potential of Intestinal Microbiota Transplantation (IMT) to restore healthy gut bacteria in participants with CHF. IMT is already an approved treatment for infectious diarrhea, with over 10,000 procedures performed each year in the US. Early findings suggest that IMT might improve heart function by balancing gut bacteria, which can influence inflammation and heart health. Although more research is needed specifically for CHF, the mechanism of IMT offers hope for its potential benefits.12367
Who Is on the Research Team?
Melana Yuzefpolskaya, MD
Principal Investigator
Columbia University
Are You a Good Fit for This Trial?
This trial is for adults with chronic heart failure (either reduced or preserved ejection fraction, NYHA Class II-IV) who are on stable treatment and can swallow capsules. People with certain gut diseases, severe allergies, recent cancer treatments, organ transplants, pregnancy, or very limited life expectancy cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Antibiotic Preconditioning
Participants receive antibiotic preconditioning with Vancomycin and Neomycin for 7 days
IMT Treatment
Participants receive Intestinal Microbiota Transplantation (IMT) daily for 7 days
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
What Are the Treatments Tested in This Trial?
Interventions
- Intestinal Microbiota Transplantation
Trial Overview
The study tests whether replacing gut bacteria using healthy donor microbiota capsules (IMT), after antibiotics neomycin and vancomycin to clear existing bacteria, helps people with chronic heart failure. Participants will be monitored through follow-up visits.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Melana Yuzefpolskaya, MD
Lead Sponsor
Citations
Intestinal Microbiota Transplantation in Patients With ...
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 ...
Microbiome and Heart Failure: A Comprehensive Review of ...
Further impacting HF outcomes are comorbidities such as diabetes, obesity, and chronic renal disease, which intensify gut dysbiosis. The ...
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ctv.veeva.com
ctv.veeva.com/study/intestinal-microbiota-transplantation-in-patients-with-chronic-heart-failureIntestinal Microbiota Transplantation in Patients With Chronic ...
IMT aims to restore healthy gut bacteria in patients with CHF, with previous studies showing its effectiveness, but further research is needed.
Long-term follow-up study on the impact of a gut microbiota ...
This study thus aims to assess the relationship between DI-GM and heart failure risk, its influence on mortality outcomes, and to investigate whether C-reactive ...
Gut microbiota in heart failure and related interventions
We reviewed how changes in metabolites of the gut microbiota contribute to heart failure and possible underlying mechanisms. We also reviewed ...
Long-Term Safety Outcomes of Fecal Microbiota ...
The causes of death included pneumonia (n = 2), renal failure (n = 1), suicide and polytrauma (n = 1), and hypoglycemia with poor neurological ...
Decoding the impact of gut microbiota on heart failure
The gut microbiota is intricately linked to prevalent risk factors for heart failure, including hypertension, diabetes, obesity, and renal insufficiency.
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