At a glance
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Pre-Study of Wild Type Enterotoxigenic E. Coli (ETEC) Strain for Verification of a Planned Challenge Dose
In Brief
A clinical study evaluating Enterotoxigenic E. coli (ETEC) strain for ETEC Diarrhea. Completed, enrolled 23 participants across 1 site.
Detailed Summary
This was an open-label, single-site pre-study designed to evaluate the safety, tolerability, and infectivity of wild-type Enterotoxigenic Escherichia coli (ETEC) strain E24377A in healthy adults. The aim was to estimate the incidence of moderate and severe diarrhea following oral challenge with approximately 4 × 10⁹ colony forming units (cfu) of the strain. A total of 23 participants were enrolled and monitored in an inpatient setting after receiving a single challenge dose. Clinical signs, symptoms, and stool output were assessed over 120 hours. This challenge model was developed to support a future controlled human infection study (CHIM) evaluating an oral inactivated ETEC vaccine.
Study Details
Timeline
Interventions
Challenge strain