NCT02802059

E. Coli Nissle 1917 - Suspension for Infection Prophylaxis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 567 (actual)
• Sponsor: Ardeypharm GmbH · Industry
• Sex: All
• Age: 120 Hours
• Healthy volunteers: Accepted

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.

Detailed description

In the course of the present trial the participants will be observed during the first 24 months of life, starting right after birth. All newborns meeting all inclusion criteria and non-fulfilling any exclusion criteria will be included into the trial. Each participant of this clinical trial will be randomly allocated to one of the two trial arms, by using the method of randomly permuted blocks. The newborns will be primarily treated during the first three weeks of life and re-treated after 6 and 12 months according to trial interventional plan. Data on the efficacy and safety will be recorded during control visits after first month, 6, 12, 18 and 24 months. A follow-up examination of study participants will be performed two years after the end of the participation in the present trial (i.e. at an age of 48 months), during which each child will be examined for its normal physical and cognitive development (covered by the U8 standardized examination). In addition data on allergic/atopic complaints or symptoms will be recorded. In an additional non-clinical explorative evaluation, it will furthermore be investigated whether the early intestinal colonization with E.coli strain Nissle 1917 affects the establishment of the intestinal microbiota. Therefore stool samples of study participants will be collected at an age of 24 and 48 months. The microbial composition of these samples will be characterized and compared between the two trial arms (EcN vs. placebo).

Conditions

• Infections

Interventions

Type	Name	Description
DRUG	EcN-Suspension	Initial administration not later than 120h after birth. 14 ampoules a 1 ml are administered within a time of 3 weeks (1 ampoule per day within first week and 1 ampoule every second day within the following two weeks). Subsequent re-administration after 6 and 12 months. 10 ampoules a 1 ml are administered within 10 days (1 ampoule per day).
DRUG	Placebo	Initial administration not later than 120h after birth. 14 ampoules a 1 ml are administered within a time of 3 weeks (1 ampoule per day within first week and 1 ampoule every second day within the following two weeks). Subsequent re-administration after 6 and 12 months. 10 ampoules a 1 ml are administered within 10 days (1 ampoule per day).

Timeline

• Start date: 2015-10-07
• Primary completion: 2020-10-12
• Completion: 2020-10-12
• First posted: 2016-06-16
• Last updated: 2020-10-27

Locations

6 sites across 2 countries: Germany, Poland