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New treatment option for Chronic Heart Failure
Official title Intestinal Microbiota Transplantation in Patients With Chronic Heart Failure
ClinicalTrials.gov ID: NCT07490054
What this study is testing
What is MTP-101-C encapsulated Microbiota?
MTP-101-C encapsulated Microbiota is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for chronic heart failure.
Also referred to as MTP-101-C.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Diagnosis of Heart Failure with Reduced Ejection Fraction (HFrEF) or Heart Failure with Reduced Ejection Fraction (HFpEF), New York Heart Association...
- 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...
You likely can't join if
- 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
See the full eligibility 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.
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.