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E. Coli Nissle 1917 - Suspension for Infection Prophylaxis

NCT02802059 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 567

Last updated 2020-10-27

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • ICON plc

    collaborator INDUSTRY

  • Clinscience Sp. z o.o.

    collaborator UNKNOWN

  • Ardeypharm GmbH

    lead INDUSTRY

Principal Investigators

  • Corinna Wolff, Dipl-Biophys · Ardeypharm GmbH

  • Dirk M Olbertz, MD · Klinikum Südstadt Rostock - Abteilung für Neonatologie

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
120 Hours
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-07
Primary Completion
2020-10-12
Completion
2020-10-12

Countries

  • Germany
  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02802059 on ClinicalTrials.gov