E. Coli Nissle 1917 - Suspension for Infection Prophylaxis (RONi)

Ardeypharm

Status and phase

Completed

Phase 3

Conditions

Infections

Treatments

Drug: Placebo

Drug: EcN-Suspension

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT02802059

MU 1441

2015-001763-39 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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).

Enrollment

567 patients

Sex

All

Ages

Under 120 hours old

Volunteers

Accepts Healthy Volunteers

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.