WP3 Decolonization of ESBL Carriers

WP3 aims to develop a novel and highly innovative interventional approach of recolonisation with fecal microbiota transplantation (FMT) following decolonization with oral colistin and neomycin to permanently suppress MDR-GNB and restore the intestinal, antibiotic-susceptible microbiota of patients carrying MDR-GNB. WP3 will address also the emerging threat of intestinal carriage of carbapenemase producing enterobacteriaceae (CRE).

The objectives of WP3 are:

  • To provide clinical data on the efficacy of a decontamination/recolonisation approach to suppress ESBL and CRE carriage and on the safety of using fecal microbiota transplantation for sustained re-colonization and ESBL / CRE control and
  • To obtain the first proof of concept in man of an original ESBL / CRE control strategy, designed to prevent spread of resistant strains, which would significantly decrease the risk of MDR-GNB dissemination in Europe and elsewhere.

WP3 will conduct a phase III, multicenter (4 centers in 4 countries), open, randomized controlled trial with equal allocation to the study arms: A 5-day course of oral colistin (2 Mio IU 4x/day) and neomycin sulphate (500mg 4x/day) followed by FMT with a standardized frozen stool preparation from 4 healthy donors on the second day after the end of antibiotic treatment will be compared to no intervention (the current standard of care).