E. Coli Nissle 1917 - Suspension for Infection Prophylaxis

NCT02802059 | Completed Phase 3

• 2 other identifiers: MU 14412015-001763-39
• Study Type: interventional
• Target: 567
• Locations: 2 countries
• Sites: 6

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.

Conditions

Infections

Outcome Measures

Primary Outcomes (1)

• Number of infections

  The total number of infections observed for each participant during its individual study participation standardised per month during the first 24 months of life. An infection is an episode of illness caused by: * Acute upper respiratory tract infections * Acute lower respiratory tract infections * Otitis media * Gastroenteritis * Urinary tract infections The duration of an episode of illness is defined as the time from the appearance of the first symptom of a study relevant infection to the disappearance of the last symptom. Infections that occur concurrently or one after another within a period of 7 days are only counted separately, if they belong to different groups of illness. All rhinitides that occur in the first year of a child's life are considered for the count of the primary efficacy variable. Rhinitides that occur in the second year will only be included if they were accompanied by fever (body temperature higher than 38.4°C during at least one measure).

  during the first 24 months of life

Secondary Outcomes (6)

• Severity of the course of infections considered as primary variables quantified as the "duration of infections"

  during the first 24 months of infants' life

• Severity of the course of infections considered as primary variables quantified as the "number of hospital admissions caused by infections"

  during the first 24 months of infants' life

• Severity of the course of infections considered as primary variables quantified as the "mean number of in-hospital spent days due to infections"

  during the first 24 months of infants' life

• Severity of the course of infections considered as primary variables quantified as the "number of antibiotic treatments due to infections".

  during the first 24 months of infants' life

• Severity of the course of infections considered as primary variables quantified as the "number of adverse events".

  during the first 24 months of infants' life

Study Arms (2)

EcN-Suspension

EXPERIMENTAL

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

Drug: EcN-Suspension

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

EcN-Suspension 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).

Also known as: E. coli strain Nissle 1917 bacteria

EcN-Suspension

Placebo 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

Eligibility Criteria

• Age: Up to 120 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Signed informed consent form by the parents
• 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

You may not qualify if:

• Lack of propensity/compliance of mother
• min APGAR SCORE less than 5
• 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.

Sponsors & Collaborators

• Ardeypharm GmbH: lead
• ICON plc: collaborator
• Clinscience Sp. z o.o.: collaborator

Study Sites (6)

Krankenhaus St. Elisabeth & St. Barbara

Halle, 06110, Germany

Location

Universitätsklinikum Jena - Klinik für Kinder- und Jugendmedizin

Jena, 07747, Germany

Location

Klinikum Westbrandenburg

Potsdam, 14467, Germany

Location

Klinikum Südstadt Rostock - Abteilung für Neonatologie

Rostock, 18059, Germany

Location

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

Bydgoszcz, 85-168, Poland

Location

Samodzielny Publiczny Dziecięcy Szpital Kliniczny Oddział Kliniczny Neonatologiiul

Warsaw, 02-091, Poland

Location

MeSH Terms

Conditions

Infections

Study Officials

• Corinna Wolff, Dipl-Biophys

  Ardeypharm GmbH

  STUDY DIRECTOR

• Dirk M Olbertz, MD

  Klinikum Südstadt Rostock - Abteilung für Neonatologie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2016
• First Posted: June 16, 2016
• Study Start: October 7, 2015
• Primary Completion: October 12, 2020
• Study Completion: October 12, 2020
• Last Updated: October 27, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4); PL (2)