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Trial Radar IA
Lo studio clinico NCT07490054 (IMT) per Insufficienza cardiaca cronica è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui.
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Intestinal Microbiota Transplantation in Patients With Chronic Heart Failure (IMT) Fase I 40

In arruolamento
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT07490054 (IMT) è uno studio interventistico di Fase I volto a esaminare il trattamento per Insufficienza cardiaca cronica, attualmente in arruolamento. Avviato il 1 settembre 2025, prevede di arruolare 40 partecipanti. Sotto la guida di Melana Yuzefpolskaya, MD, dovrebbe concludersi entro il 1 novembre 2026. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 24 marzo 2026.
Sommario breve
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 t...Mostra di più
Descrizione dettagliata
Hypothesis: CHF is thought to be partly mediated by inflammation. The primary hypotheses are anchored in the premise that the pathophysiology of CHF is in part driven by inflammation arising from low diversity, dysbiotic intestinal microbiota through at least three mechanisms including: i) enrichment of gram- negative lipopolysaccharide (LPS) producers; ii) enrichment of organisms with uremic toxin producing potentia...Mostra di più
Titolo ufficiale

An Open-Label, Pilot Clinical Trial To Test The Safety And Feasibility Of Intestinal Microbiota Transplantation In Patients With Chronic Heart Failure

Patologie
Insufficienza cardiaca cronica
Pubblicazioni
Articoli scientifici e documenti di ricerca pubblicati su questo studio clinico:
Altri ID dello studio
  • IMT
  • AAAV0014
Numero NCT
NCT07490054
Data di inizio (effettiva)
2025-09-01
Ultimo aggiornamento pubblicato
2026-03-24
Data di completamento (stimata)
2026-11
Arruolamento (previsto)
40
Tipo di studio
Interventistico
FASE
Fase I
Stato
In arruolamento
Parole chiave
Heart Failure
Intestinal Microbiota Transplantation
Heart Failure with Reduced Ejection Fraction
Heart Failure with Preserved Ejection Fraction
Scopo principale
Trattamento
Allocazione
N.D.
Modello di intervento
A gruppo singolo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
SperimentaleParticipants with Chronic Heart Failure (CHF)
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 s...Mostra di più
MTP-101-C encapsulated Microbiota
Compound MTP-101-C was originally developed for treatment of the recurrent C. difficile infection syndrome (rCDI) following completion of anti-C. difficile antibiotic course. Fecal microbiota is prepared from stool of healthy human donors, who are screened and tested for infectious and non-infectious diseases. Raw stool is homogenized and filtered to separate the microbiota. The fecal microbiota is frozen in the pres...Mostra di più
Vancomicina
glycopeptide antibiotic
Neomycin
aminoglycoside antibiotic
Esito primario
Misure di esitoDescrizione della misuraArco temporale
Number of Adverse Events
Safety will be measured by the number of adverse events that occur in participants.
Day 180
Study Drug Adherence
Study drug adherence (compliance) will be measured as the number of participants taking 100% (all doses) of the IMT.
Day 14
Assistente alla partecipazione
Criteri di eleggibilità

Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
  • 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 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
Melana Yuzefpolskaya, MD logoMelana Yuzefpolskaya, MD
Parte responsabile dello studio
Melana Yuzefpolskaya, MD, Promotore-investigatore, Associate Professor of Medicine, Columbia University
Contatti principali dello studio
Contatto: Annamaria Ladanyi, MD, 2123426058, [email protected]
1 Centri dello studio in 1 paesi

New York

Columbia University Irving Medical Center, New York, New York, 10032, United States
Annamaria Ladanyi, MD, Contatto, 212-342-6058, [email protected]
Melana Yuzefpolskaya, MD, Investigatore principale
Paolo Colombo, MD, Sub-investigatore
Ryan Demmer, PhD, Investigatore principale
In arruolamento