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Improving Nutrition for Babies Born by Caesarean Section

Study acronym: SPECIFI-C
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Sep 17, 2028 to Sep 30, 2028
    • Start date changed from estimate of Sep 17, 2025 to Sep 30, 2025
    • Site details revised
    v3
  2. Primary endpoint revisedv2 Show 4 more changesShow less
    • Primary and study completion dates: Sep 15, 2028 to Sep 17, 2028
    • Start date: Sep 15, 2025 to Sep 17, 2025
    • Secondary endpoints shortened, about 78 words
    • Study description expanded, about 6 words
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07162025
Lead Sponsor Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Conditions
(from sponsor)		 Breastfeeding Mothers of Legal Age, Their Babies Under 6 Months Old Born Vaginally
Related terms Breast Feeding
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov