Characterization of Resistance Against Live-attenuated Diarrhoeagenic E. Coli

NACompletedINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

September 30, 2015

Primary Completion Date

March 31, 2016

Study Completion Date

January 31, 2017

Conditions
DiarrheaGastroenteritisBacterial InfectionsEscherichia Coli Infections
Interventions
BIOLOGICAL

E. coli strain E1392-75-2A

"At study day 14, after a standardized evening meal and an overnight fast, subjects will receive a single oral dose of the attenuated diarrhoeagenic E. coli strain E1392-75-2A (dose will be either 1E10 CFU (n=22) or 5E10 CFU (n=22)). Oral challenge will occur at 10.00 AM. Under supervision of the project team, subjects will get a NaHCO3 solution (100 ml 2% NaHCO3) to neutralize the gastric acid. After 5 minutes, they get a fruit juice (100 ml) containing the attenuated diarrhoeagenic E. coli strain at the above-mentioned dose. Subjects go home, but are not allowed to drink or eat for 1 hour.~At study day 35, after a standardized evening meal and an overnight fast, all subjects will receive a second inoculation 1E10 CFU of the diarrhoeagenic E. coli."

Trial Locations (2)

6718ZB

NIZO food research, Ede

Unknown

Hospital Gelderse Vallei, Ede

All Listed Sponsors
lead

NIZO Food Research

OTHER

NCT02541695 - Characterization of Resistance Against Live-attenuated Diarrhoeagenic E. Coli | Biotech Hunter | Biotech Hunter