Improving Nutrition for Babies Born by Caesarean Section

NCT07162025 | Recruiting

• 1 other identifier: 2025-A00676-43
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breastfeeding Mothers of Legal Age; Their Babies Under 6 Months Old Born Vaginally

Keywords

caesarean section; breastfeeding

Outcome Measures

Primary Outcomes (1)

• Measurement of the viability of supplemented probiotic microorganisms (CFU/g) and levels of bioactive lipids in the experimental infant formula specifically designed for cesarean-born infants

  up to 3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Breastfeeding mothers and their babies under 6 months old

You may qualify if:

• Breastfeeding mothers:
• Aged 18 years and older Breastfeeding for less than 6 months Not having taken probiotics in the 6 months prior to sampling Not having taken antibiotics in the 6 months prior to sampling No chronic medical conditions Not undergoing chronic treatment No history of gestational diabetes Body mass index (BMI) below 25 at the start of pregnancy Having given their consent to participate in the study and to the collection of their baby's stool samples Not deprived of liberty or placed under guardianship

You may not qualify if:

• Breastfeeding mothers:
• Under the age of 18
• Breastfeeding for 6 months or more
• Having been on antibiotic therapy in the 6 months prior to sampling
• Having taken probiotics in the 6 months prior to sampling
• Having a chronic illness
• Undergoing chronic treatment
• Who have developed gestational diabetes
• Who have a BMI greater than 25 at the start of pregnancy
• Who have given their consent to participate in the study (breast milk collection) but not to the collection of their baby's stool samples
• Who are deprived of their liberty or under guardianship.
• Babies:
• Aged over 6 months
• Born by caesarean section
• Born before 37 weeks of pregnancy

Sponsors & Collaborators

• Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement: lead

Study Sites (1)

INRAE

Jouy-en-Josas, 78350, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Fecal samples and human breast milk

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Central Study Contacts

REBECA MARTIN-ROSIQUE, PhD

CONTACT

00 33 1 34 65 20 98; rebeca.martin-rosique@inrae.fr

ELISE BOREZEE, PhD

CONTACT

elise.borezee@inrae.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 9, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: November 19, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)