E. coli Nissle 1917 - Suspension for infection prophylaxis

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 558

Inclusion Criteria

- Signed informed consent form by the parents
- Age at first intake of trial medication: max. 120 hours after birth
- Functionally mature infant
- Gestational age more than 35th week of development
- Intention of the mother to breast feed the participant
- Readiness of the mother to administer no probiotics additionally to the trial medication to the participant during entire course of the study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 558
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective is to show that the administration of E.coli strain Nissle 1917 results in the reduction of the number of both bacterial and viral infections during the first 24 months of infant’s life.;Secondary Objective: The secondary objectives are to show that the administration of E. coli strain Nissle reduces of the severity of the course of the infections considered as primary variables and to reveal that the trial medication is generally well tolerated.;Timepoint(s) of evaluation of this end point: After observation period of 24 months.;Primary end point(s): The number of following infections confirmed by paediatricians’ diagnoses:<br><br>- Acute upper respiratory tract infections (i.e. rhinopharyngitis, laryngitis, angina tonsillitis, tracheitis)<br>- Acute lower respiratory tract infections (i.e. bronchitis, bronchiolitis, bronchopneumonia, pneumonia)<br>- Otitis media<br>- Gastroenteritis<br>- Urinary tract infections

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: After observation period of 24 months.;Secondary end point(s): The reduction of the severity of the course of the infections considered as primary variables:<br>- Duration of the infection (number of days with at least one symptom)<br>- Number of hospital admissions caused by infections<br>- Mean number of in-hospital spent days<br>- Number of antibiotic treatments<br>- Adverse events <br>- Tolerance to trial medication<br>

Related Trials