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

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ClinicalTrials.gov Identifier: NCT02802059
Recruitment Status : Recruiting
First Posted : June 16, 2016
Last Update Posted : August 8, 2018
Sponsor:
Collaborator:
ICON plc
Information provided by (Responsible Party):
Ardeypharm GmbH

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.

Condition or disease Intervention/treatment Phase
Infections Drug: EcN-Suspension Drug: Placebo Phase 3

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).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 558 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: E. Coli Nissle 1917 - Suspension for Infection Prophylaxis
Study Start Date : October 2015
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: EcN-Suspension
279 healthy functionally mature newborn infants up to 35 weeks gestational age, treated with EcN-Suspension
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).

Other Name: E. coli strain Nissle 1917 bacteria

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





Primary Outcome Measures :
  1. Number of infections confirmed by M.D. [ Time Frame: during the first 24 months of infants' life ]

    The following bacterial and viral infections will be counted and added up to receive the total number of infections, i.e. the primary outcome measure:

    • Acute upper respiratory tract infections (i.e. rhinopharyngitis, laryngitis, angina tonsillitis, tracheitis)
    • Acute lower respiratory tract infections (i.e. bronchitis, bronchiolitis, bronchopneumonia, pneumonia)
    • Otitis media
    • Gastroenteritis
    • Urinary tract infections


Secondary Outcome Measures :
  1. Severity of the course of infections considered as primary variables quantified as the "duration of infections" [ Time Frame: during the first 24 months of infants' life ]
    duration of infection = the number of days with at least one symptom

  2. Severity of the course of infections considered as primary variables quantified as the "number of hospital admissions caused by infections" [ Time Frame: during the first 24 months of infants' life ]
    number of hospital admissions caused by infections

  3. Severity of the course of infections considered as primary variables quantified as the "mean number of in-hospital spent days due to infections" [ Time Frame: during the first 24 months of infants' life ]
    mean number of in-hospital spent days due to infections

  4. Severity of the course of infections considered as primary variables quantified as the "number of antibiotic treatments due to infections". [ Time Frame: during the first 24 months of infants' life ]
    number of antibiotic treatments due to infections

  5. Severity of the course of infections considered as primary variables quantified as the "number of adverse events". [ Time Frame: during the first 24 months of infants' life ]
    number of adverse events

  6. Severity of the course of infections considered as primary variables quantified as the "tolerance to trial medication". [ Time Frame: during the first 24 months of infants' life ]
    Tolerance of trial medication will be assessed by the investigator and scored "very good", "good", "moderate", or "poor".



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Ages Eligible for Study:   up to 120 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02802059


Contacts
Contact: Corinna Wolff, Dipl-Biophys corinna.wolff@ardeypharm.de

Locations
Germany
Krankenhaus St. Elisabeth & St. Barbara Recruiting
Halle (Saale), Germany, 06110
Contact: Ludwig Patzer, MD       l.patzer@krankenhaus-halle-saale.de   
Principal Investigator: Ludwig Patzer, MD         
Sub-Investigator: Klaus Oettel, MD         
Universitätsklinikum Jena - Klinik für Kinder- und Jugendmedizin Recruiting
Jena, Germany, 07747
Contact: Hans Proquitté, MD       hans.proquitte@med-uni-jena.de   
Principal Investigator: Hans Proquitté, MD         
Sub-Investigator: Kristin Dawczynski, MD         
Klinikum Westbrandenburg Recruiting
Potsdam, Germany, 14467
Contact: Thomas Erler, MD       terler@klinikumwb.de   
Principal Investigator: Thomas Erler, MD         
Sub-Investigator: Vivian Richter         
Klinikum Südstadt Rostock - Abteilung für Neonatologie Recruiting
Rostock, Germany, 18059
Contact: Dirk M Olbertz, MD       dirk.olbertz@kliniksued-rostock.de   
Principal Investigator: Dirk M Olbertz, MD         
Sub-Investigator: Volker Schmidt, MD         
Poland
Jan Biziel University Hospital No. 2 in Bydgoszcz Recruiting
Bydgoszcz, Poland, 85-168
Contact: Iwona Sadowska-Krawczenko, MD.       iwonasadowska@cm.umk.pl   
Principal Investigator: Iwona Sadowska-Krawczenko, MD         
Independent Public Children's Clinical Hospital Recruiting
Warsaw, Poland, 02-091
Contact: Aleksandra Mikolajczak, MD       aleksandra.mikolajczak@spdsk.edu.pl   
Principal Investigator: Aleksandra Mikolajczak, MD         
Sponsors and Collaborators
Ardeypharm GmbH
ICON plc
Investigators
Study Director: Corinna Wolff, Dipl-Biophys Ardeypharm GmbH
Principal Investigator: Dirk M Olbertz, MD Klinikum Südstadt Rostock - Abteilung für Neonatologie

Responsible Party: Ardeypharm GmbH
ClinicalTrials.gov Identifier: NCT02802059     History of Changes
Other Study ID Numbers: MU 1441
2015-001763-39 ( EudraCT Number )
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Infection
Communicable Diseases