Improving Nutrition for Babies Born by Caesarean Section

The ambition of the project is to help with the primal colonisation of babies born by caesarean section and to improve the lipid composition of an infant formula, in order to reduce the short- and long-term health problems associated with caesarean births. This population, which represents around 20% of babies born in France, has not yet received any specific care to date. The study aims to develop an optimized infant formula. It includes: (1) isolation of probiotics from breast milk from nursing mothers and stool samples from their babies born vaginally, (2) formulation of an improved milk enriched with physiological lipids and selected probiotics, and (3) preclinical evaluation of its beneficial effects in a cesarean birth model.

NCT Number	NCT07162025
Lead Sponsor	Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Conditions	Breastfeeding Mothers of Legal Age, Their Babies Under 6 Months Old Born Vaginally
Enrollment	40 participants
Start Date	2025-09-30
Primary Completion	2028-09-30 (estimated)
Study Completion	2028-09-30 (estimated)
Updated on ClinicalTrials.gov	2025-11-19