Cesarean Section Study
Not Applicable
Completed
- Conditions
- DiarrheaAtopic Dermatitis
- Interventions
- Dietary Supplement: Probiotic
- Registration Number
- NCT01992497
- Lead Sponsor
- Société des Produits Nestlé (SPN)
- Brief Summary
Effect, tolerance and safety of a supplementation with a probiotic on the risk of gastrointestinal infections, on growth, and on gut microbiota in healthy newborn term infants born by Cesarean section. Exploratory comparison between a probiotic vs. placebo in the formula-fed and in the breastfed feeding groups.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 721
Inclusion Criteria
- written informed consent must be obtained from legal guardian(s) prior to randomization or any study related procedures
- healthy newborns
- born by Cesarean section
- singleton birth
- Age at enrollment in the study < 24h
- birth weight ≥ 2500g and ≤ 4300g
- gestational age ≥ 37 weeks and ≤ 42 weeks
Exclusion Criteria
- congenital diseases or malformations that may inhibit growth
- prenatal and/or postnatal diseases
- parents are expected to have difficulty complying with the feeding regime
- planned re-admittance to the hospital in the first 14 days of life
- antibiotic treatment at the time of enrollment in the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Formula + placebo Probiotic - Breastfed + placebo Probiotic - Formula + probiotic Probiotic Formula + probiotic Breastfed + probiotic Probiotic Breastfed + probiotic
- Primary Outcome Measures
Name Time Method Number of diarrhea episodes between a probiotic vs. placebo 12 months
- Secondary Outcome Measures
Name Time Method Diarrhea duration between a probiotic vs. placebo 12 months
Trial Locations
- Locations (1)
Klinikum Ernst v. Bergmann GmbH
🇩🇪Potsdam, Germany