Overview

E. Coli Nissle 1917 - Suspension for Infection Prophylaxis

Status:
Completed
Trial end date:
2020-10-12
Target enrollment:
Participant gender:
Summary
This study evaluates the long term effects of E. coli strain Nissle 1917 (EcN-Suspension) probiotic bacteria administration on the number of both, bacterial and viral infections during the first 24 months of infant's life. Half of study participants will receive EcN-Suspension, while the other half will receive placebo. In an additional non-clinical explorative evaluation will furthermore be investigated whether the early intestinal colonization with E.coli strain Nissle 1917 affects the establishment of the intestinal microbiota.
Phase:
Phase 3
Details
Lead Sponsor:
Ardeypharm GmbH
Collaborators:
Clinscience Sp. z o.o.
ICON plc