Cesarean Section Study

Effect,Tolerance and Safety of a Supplementation With a Probiotic in Healthy Newborn Term Infants Born by Cesarean Section Over a 12 Months Period Study

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.

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