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Improving Nutrition for Babies Born by Caesarean Section

Recruitingn/aAges 18 Years - anyAllInstitut National de Recherche pour l'Agriculture…
NCT07162025 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

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📋 Eligibility rules (as published)
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
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What it tests

  • Not listed
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Where

1 site
INRAE
Jouy-en-Josas, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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