NCT04991792

Effect of an Infant Formula With Synbiotics in Infants Born Via Caesarean Section

Evaluation of the Effect of an Infant Formula Containing Synbiotics on the Composition of the Gut Microbiota in Infants Born Via Caesarean Section

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 486 (actual)
• Sponsor: HiPP GmbH & Co. Vertrieb KG · Industry
• Sex: All
• Age: 4 Days – 6 Days
• Healthy volunteers: Accepted

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.

Detailed description

Since caesarean section (CS)-born infants show dysbiotic microbial colonization during the first weeks of life, exclusive breastfeeding is the feeding mode of choice for these infants. However, since CS births are often associated with breast-feeding difficulties, it is of importance to feed an microbiota-supportive infant formula. This study is designed to investigate whether an infant formula supplemented with synbiotics positively affects the microbial composition, gastrointestinal characteristics and the proper function of the immune system in CS-born infants, compared to feeding a standard infant formula without synbiotics in either CS- and vaginal-born infants during the first 6 months of life. The growth of the infants as well as tolerance, infectious diseases and allergies will also be assessed. In order to investigate the effect of different birth modes and feeding conditions on the microbiota, the study population will include healthy term infants, born either by CS or by VD, additional groups receive human milk or formula with prebiotics only. Additionally, if the parents agree, their infant will be followed up until 24 months of age with a special focus on the prevention of infections and allergies.

Conditions

• Gut Microbiota

Interventions

Type	Name	Description
OTHER	Intervention Group 1: Infant Formula with synbiotics	Infants will receive infant formula during the first 6 months of life
OTHER	Intervention Group 2: Infant Formula with prebiotics	Infants will receive infant formula during the first 6 months of life
OTHER	Control Group 1 and 2: Infant Formula without synbiotics	Infants will receive infant formula during the first 6 months of life

Timeline

• Start date: 2021-09-23
• Primary completion: 2022-11-29
• Completion: 2024-07-07
• First posted: 2021-08-05
• Last updated: 2025-05-06

Locations

1 site across 1 country: Bulgaria