E. Coli Nissle 1917 - Suspension for Infection Prophylaxis

• Status: Completed
• Trial end date: 2020-10-12
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ardeypharm GmbH
• Collaborators: Clinscience Sp. z o.o.; ICON plc

Criteria

Inclusion Criteria:

• Signed informed consent form by the parents

• Age at inclusion: max. 120 hours after birth

• Functionally mature infant

• Gestational age more than 35th week of development

• Mother's intention to breastfeed the participant

• Readiness of the mother to administer no probiotics additionally to the trial medication

Exclusion Criteria:

• Non-fulfilment of the at least one inclusion criteria

• Lack of propensity/compliance of mother

• 5 min APGAR SCORE less than 5

• 10 min APGAR SCORE less than 8

• pH of umbilical cord blood less than 7 (Determination not obligatory, if APGAR SCORES do not indicate that the child may have suffered from a perinatal asphyxia)

• Any perinatal infection required antibiotic treatment

• Birth weight less than 2000 g

• TORCH-infection of the mother

• HIV-infection of the mother

• Any severe medical condition of mother or newborn which in the opinion of the investigator may have a critical impact on the conduct of the study.