Intestinal Microbiota Transplantation in Patients With Chronic Heart Failure
An Open-Label, Pilot Clinical Trial To Test The Safety And Feasibility Of Intestinal Microbiota Transplantation In Patients With Chronic Heart Failure
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 6 months
- Procedures mentioned: Questionnaires, Interviews, Blood draws
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Patients will undergo follow-up either by phone, video or in-person visit, or online survey of symptoms on days 1-21, and then monthly up to 6 months post-IMT to screen for serious adverse events (SAEs) and adverse events (AEs)."
- "Screening for SAEs and AEs will be done using a symptom questionnaire as well as by asking patients during our interview."
- "Blood samples and a fecal sample will be collected from participants on months one and six post-IMT to assess circulating inflammatory mediators and to assess for changes in recipient microbiome (engraftment kinetics)."
- "At six months, patients will also undergo repeat six-minute walk test, echocardiogram, and quality of life questionnaire when logistically possible and clinically indicated."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether replacing gut bacteria with bacteria from a healthy donor can help people with chronic heart failure. This treatment is called intestinal microbiota transplantation (IMT). It is not approved for heart failure and is still being studied.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have heart failure of a listed type (HFrEF or HFpEF), with symptoms rated New York Heart Association class II–IV.
- Have been on stable heart failure treatment for at least one month before joining.
- Can swallow capsules.
- Can give blood and stool samples.
- Are willing to follow all study steps and stay available for follow-up by phone, in person, email, or video.
Who can't join
- Trouble swallowing pills; active inflammatory bowel disease; celiac disease; or an ileostomy or colostomy (an opening in the belly for stool to leave the body).
- On a transplant waiting list, or expected to be listed or receive a heart pump called an LVAD within 6 months; or a past organ or bone marrow transplant.
- Sudden heart muscle inflammation, or heart muscle disease caused by thickening or a buildup of substances.
- Kidney disease needing dialysis (a treatment that filters blood), or expected to live less than 6 months.
- Pregnant or breastfeeding. Those who could become pregnant must have a negative pregnancy test before IMT.
- Taking medicines that weaken the immune system, or having a very low count of neutrophils (white blood cells that fight infection).
- Expected to need antibiotics often, or a history of a severe, life-threatening food allergy.
- Receiving cancer treatment with chemotherapy, immunotherapy, or radiation.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 sites (1)
NY
- Columbia University Irving Medical Center · New York, NY 10032Annamaria Ladanyi, MD · Study contact · 212-342-6058 · al4285@cumc.columbia.eduMelana Yuzefpolskaya, MD · Principal investigatorPaolo Colombo, MD · Sub-investigatorRyan Demmer, PhD · Principal investigatorMore trials in New York