Improving Nutrition for Babies Born by Caesarean Section
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
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
Trial population
Breastfeeding mothers and their babies under 6 months old
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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
Time frame
up to 3 yearsSponsors and contacts
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Source ClinicalTrials.gov