Improving nutrition for babies born by C-section
Development of a Specific Infant Formula for Babies Born by Caesarean Section
The project will test a new infant formula, developed using probiotics and physiological lipids sourced from breastfeeding mothers and vaginally born babies, to help babies born by C-section establish healthier gut microbiota.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement Academic / other |
| Locations | 1 site (Jouy-en-Josas) |
| Trial ID | NCT07162025 on ClinicalTrials.gov |
What this trial studies
This project isolates beneficial microbes from breast milk and stool of vaginally born, exclusively breastfed infants and their mothers, then selects strains to include in a reformulated infant milk enriched with physiological lipids. The selected probiotics and lipid profile will be combined to create an optimized formula designed to support primary gut colonization in infants lacking maternal vaginal exposure. Preclinical testing will be performed in a cesarean birth model to measure effects on microbiota, metabolic markers, and immune-related outcomes. The work aims to produce a candidate formula for further clinical testing in C-section–born infants.
Who should consider this trial
Good fit: The intended beneficiaries are infants born by cesarean section, particularly those in the early months of life when primary colonization occurs.
Not a fit: Babies born vaginally or infants with contraindications to probiotic supplements or modified lipid formulas are unlikely to benefit from this specific intervention.
Why it matters
Potential benefit: If successful, a tailored infant formula could help restore healthier early gut colonization after C-section and reduce associated short- and long-term health risks.
How similar studies have performed: Breastfeeding and approaches like maternal vaginal or fecal microbiota transfer have shown partial success in restoring microbiota, but formula-based strategies targeting C-section colonization are novel and largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: 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
Where this trial is running
Jouy-en-Josas
- Inrae — Jouy-en-Josas, France (Recruiting)
Study contacts
- Study coordinator: REBECA MARTIN-ROSIQUE, PhD
- Email: rebeca.martin-rosique@inrae.fr
- Phone: 00 33 1 34 65 20 98
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.