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Die klinische Studie NCT07490054 (IMT) für Chronische Herzinsuffizienz ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen.
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Intestinal Microbiota Transplantation in Patients With Chronic Heart Failure (IMT) Phase 1 40

Offene Rekrutierung
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT07490054 (IMT) untersucht Behandlung im Zusammenhang mit Chronische Herzinsuffizienz. Diese interventionsstudie der Phase 1 hat den Status offene rekrutierung und startete am 1. September 2025. Es ist geplant, 40 Teilnehmer aufzunehmen. Durchgeführt von Melana Yuzefpolskaya, MD wird der Abschluss für 1. November 2026 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 24. März 2026 aktualisiert.
Kurzbeschreibung
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...Mehr anzeigen
Ausführliche Beschreibung
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...Mehr anzeigen
Offizieller Titel

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

Erkrankungen
Chronische Herzinsuffizienz
Publikationen
Wissenschaftliche Artikel und Forschungspapiere zu dieser klinischen Studie:
Weitere Studien-IDs
  • IMT
  • AAAV0014
NCT-Nummer
NCT07490054
Studienbeginn (tatsächlich)
2025-09-01
Zuletzt aktualisiert
2026-03-24
Studienende (vorauss.)
2026-11
Geplante Rekrutierung
40
Studientyp
Interventionsstudie
PHASE
Phase 1
Status
Offene Rekrutierung
Stichwörter
Heart Failure
Intestinal Microbiota Transplantation
Heart Failure with Reduced Ejection Fraction
Heart Failure with Preserved Ejection Fraction
Primäres Ziel
Behandlung
Zuteilungsmethode
Nicht zutreffend
Interventionsmodell
Einarmige Studie
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellParticipants 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...Mehr anzeigen
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...Mehr anzeigen
Vancomycin
glycopeptide antibiotic
Neomycin
aminoglycoside antibiotic
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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
Teilnahme-Assistent
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
  • 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
Verantwortliche Partei
Melana Yuzefpolskaya, MD, Prüfsponsor, Associate Professor of Medicine, Columbia University
Zentrale Studienkontakte
Kontakt: Annamaria Ladanyi, MD, 2123426058, [email protected]
1 Studienstandorte in 1 Ländern

New York

Columbia University Irving Medical Center, New York, New York, 10032, United States
Annamaria Ladanyi, MD, Kontakt, 212-342-6058, [email protected]
Melana Yuzefpolskaya, MD, Hauptprüfer
Paolo Colombo, MD, Prüfarzt
Ryan Demmer, PhD, Hauptprüfer
Offene Rekrutierung