Effect of an Infant Formula With Synbiotics in Infants Born Via Caesarean Section
Effect of an Infant Formula With Synbiotics in Infants Born Via Caesarean Section
NCT ID: NCT04991792 Phase: NA Status: COMPLETED Enrollment: 486 Completion: 2024-07-07
Conditions
Gut Microbiota
Interventions
Intervention Group 1: Infant Formula with synbiotics, Intervention Group 2: Infant Formula with prebiotics, Control Group 1 and 2: Infant Formula without synbiotics
Summary
A multi-centre, randomized, parallel-group, double-blind, controlled, exploratory clinical trial is conducted to assess the positive effect of feeding a formula containing synbiotics (pre- and probiotics) on the composition of the gut microbiota in caesarean section (CS) born healthy term infants within the first 6 months of life.
Primary Outcome
Assessment whether an infant formula containing synbiotics positively affects the composition of the gut microbiota in CS-born infants compared to a standard formula (without synbiotics) or breast-feeding within the first 6 months of life