💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
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