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Metabolomic Profile in Breastfed Late Preterm Infants

NCT06052592 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 54

Last updated 2024-09-19

No results posted yet for this study

Summary

Exclusive breast milk is recommended from birth to 6 months of life to promote the development of a balanced intestinal microbiota. Human milk provides several bioactive components, from natural probiotics such as Bifidobacterium spp. and Lactobacillus spp., to their metabolites which colonize the intestine of the newborn. However, if breast milk is not available or insufficient, it is used formula milk as a substitute. Infant formula can be supplemented with postbiotics to promote maturation of immune, metabolic and microbial components, similar to breast milk. Postbiotics are preparations composed of both microbial constituents and their metabolites, produced during fermentation.

Conditions

  • Formula Milk
  • Breast Milk Collection
  • Postbiotic Supplemented Formula Milk

Interventions

OTHER

Milk

Newborns will be fed with breast milk, formula milk or postbiotic formula milk

Sponsors & Collaborators

  • University of Salerno

    collaborator OTHER

  • Ospedale Buon Consiglio Fatebenefratelli

    lead OTHER

Principal Investigators

  • Giuseppe De Bernardo, MD · Ospedale Buon Consiglio Fatebenefratelli

Eligibility

Min Age
34 Weeks
Max Age
37 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2023-11-01
Completion
2023-11-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06052592 on ClinicalTrials.gov