Status:
RECRUITING
Improving Nutrition for Babies Born by Caesarean Section
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
Eligibility:
All Genders
18+ years
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 lon...
Detailed Description
The perinatal period represents a critical window during which the establishment of the infant gut microbiota plays a central role in host physiology and immune system development. Cesarean delivery i...
Eligibility Criteria
Inclusion
- 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
- \- Babies: Aged less than 6 months Born vaginally Born at term or at least 37 weeks of pregnancy Exclusively breastfed Not having received intrapartum antibiotic treatment Having no known medical conditions Not receiving any medical supplements other than conventional vitamins Whose mothers meet the inclusion criteria detailed above
Exclusion
- 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
- Not exclusively breastfed
- Having undergone intrapartum antibiotic treatment
- Taking medical supplements other than conventional vitamins
- Presenting with any type of pathology
- Whose mothers meet the non-inclusion criteria detailed above
- Receiving medical supplementation other than conventional vitamins
Key Trial Info
Start Date :
September 30 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2028
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07162025
Start Date
September 30 2025
End Date
September 30 2028
Last Update
November 19 2025
Active Locations (1)
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1
INRAE
Jouy-en-Josas, France, 78350