Cesarean Section Study

Nestlé

Status: Completed

Conditions: Atopic Dermatitis; Diarrhea

Treatments: Dietary Supplement: Probiotic

Study type: Interventional

Funder types: Industry

Identifiers

NCT01992497

12.14.INF

Details and patient eligibility

About

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.

Enrollment: 721 patients

Sex: All

Ages: 1 minute to 24 hours old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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721 participants in 4 patient groups, including a placebo group

Formula + placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Probiotic

Formula + probiotic

Experimental group

Description:

Formula + probiotic

Treatment:

Dietary Supplement: Probiotic

Breastfed + probiotic

Experimental group

Description:

Breastfed + probiotic

Treatment:

Dietary Supplement: Probiotic

Breastfed + placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Probiotic