E. Coli Nissle 1917 - Suspension for Infection Prophylaxis

NCT ID: NCT02802059

Last Updated: 2020-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 567 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-07
• Study Completion Date: 2020-10-12

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

EcN-Suspension

279 healthy functionally mature newborn infants up to 35 weeks gestational age, treated with EcN-Suspension

Group Type: EXPERIMENTAL

EcN-Suspension

Intervention Type: DRUG

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).

Placebo

279 healthy functionally mature newborn infants up to 35 weeks gestational age, treated with Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: 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).

Intervention Type: DRUG

Other Intervention Names

E. coli strain Nissle 1917 bacteria

Eligibility 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

• 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.

• Maximum Eligible Age: 120 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ICON plc

INDUSTRY

Sponsor Role: collaborator

Clinscience Sp. z o.o.

UNKNOWN

Sponsor Role: collaborator

Ardeypharm GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Corinna Wolff, Dipl-Biophys

Role: STUDY_DIRECTOR

Ardeypharm GmbH

Dirk M Olbertz, MD

Role: PRINCIPAL_INVESTIGATOR

Klinikum Südstadt Rostock - Abteilung für Neonatologie

Locations

Krankenhaus St. Elisabeth & St. Barbara

Halle, , Germany

Universitätsklinikum Jena - Klinik für Kinder- und Jugendmedizin

Jena, , Germany

Klinikum Westbrandenburg

Potsdam, , Germany

Klinikum Südstadt Rostock - Abteilung für Neonatologie

Rostock, , Germany

Oddział Kliniczny Noworodków, Wcześniaków z Intensywną Terapią Noworodka wraz z Wyjazdowym Zespołem "N"

Bydgoszcz, , Poland

Samodzielny Publiczny Dziecięcy Szpital Kliniczny Oddział Kliniczny Neonatologiiul

Warsaw, , Poland

Countries

Germany; Poland

Other Identifiers

2015-001763-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MU 1441

Identifier Type: -

Identifier Source: org_study_id