Atopic Dermatitis, Diarrhea
Conditions
Keywords
Cesarean section, probiotic, formula fed, gut microbiota
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.
Interventions
DIETARY_SUPPLEMENTProbiotic
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Minutes to 24 Hours
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of diarrhea episodes between a probiotic vs. placebo | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Diarrhea duration between a probiotic vs. placebo | 12 months |
Countries
Germany
Outcome results
None listed