E. coli Nissle 1917 - Suspension for infection prophylaxis
- Conditions
- Following viral and bacterial infections:- 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.Therapeutic area: Not possible to specify
- Registration Number
- EUCTR2015-001763-39-DE
- Lead Sponsor
- Ardeypharm GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 558
- 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
- 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
- Secondary Outcome Measures
Name Time Method