drugset / Trial / NCT05035342

Fecal Transplantation to Eradicate Colonizing Emergent Superbugs

NCT05035342

Phase 3 Recruiting 214 enrolled Assistance Publique - Hôpitaux de Paris
RandomizedParallel-groupQuadruple-blindSupportive care

Summary

Carriage of multi-drug and extensive-drug resistant Gram negative bacteria (MDR-GNB) is associated with an increased risk of infections by these bacteria for the carriers and a high risk of dissemination both in the healthcare setting and the community; the main MDR-GNB reservoir is the fecal microbiota. To prevent both infections and dissemination, effective measures to decolonize subjects carrying MDR-GNB are urgently needed. Animal models, case reports and cohort studies suggest fecal microbiota transplantation (FMT) may be efficient for MDR-GNB decolonization.

Timeline

Start
2024-01-11
Primary completion
2026-05
Completion
2028-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Fecal Microbiota Transplantation (FMT) Other / unclassified 50 g