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Metabolomic Profile of Urine Samples From Neonates Fed With Breast Milk and an Infant Formula Enriched With Synbiotics

NCT03320837 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 108

Last updated 2023-11-22

No results posted yet for this study

Summary

The aim of this trial is to verify - based on metabolomics and other anthropometric parameters - whether exclusive nutrition of infant formula enriched with synbiotics (probiotics B.lactis and prebiotics FOS), Long-Chain Polyunsaturated Fatty Acids (AA, DHA) and nucleotides, is comparable to breast milk and to mixed nutrition including breast milk together with the enriched infant formula.

Conditions

  • Infant Development

Interventions

DIETARY_SUPPLEMENT

Infant formula

Breast milk substitute containing synbiotics

OTHER

Breast milk

Breast milk

Sponsors & Collaborators

  • National and Kapodistrian University of Athens

    collaborator OTHER

  • National Hellenic Research Foundation

    collaborator OTHER

  • Rontis Hellas SA

    lead INDUSTRY

Principal Investigators

  • Nicoletta Iacovidou, PhD · National and Kapodistrian University of Athens

Eligibility

Min Age
1 Day
Max Age
28 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2022-04-29
Completion
2022-12-15

Countries

  • Greece

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 NCT03320837 on ClinicalTrials.gov