Status:
COMPLETED
Metabolomic Profile of Urine Samples From Neonates Fed With Breast Milk and an Infant Formula Enriched With Synbiotics
Lead Sponsor:
Rontis Hellas SA
Collaborating Sponsors:
National and Kapodistrian University of Athens
National Hellenic Research Foundation
Conditions:
Infant Development
Eligibility:
All Genders
1-28 years
Brief 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 prebiot...
Detailed Description
Normal full-term infants aged 0-28 days, from singlet pregnancy, born by vaginal delivery or by caesarian section, with Apgar score \>7 in the 1st and 5th minute, not requiring resuscitation during de...
Eligibility Criteria
Inclusion
- Normal full-term infants aged 0-28 days,
- From singlet pregnancy,
- Born by vaginal delivery or by caesarian section, with Apgar score \>7 in the 1st and 5th minute,
- Not requiring resuscitation during delivery, and with a normal intrauterine growth, i.e. between 11th and 89th percentile (AGA- appropriate for gestational age).
Exclusion
- Insufficient weight gain and/or semiology of possible allergy to cow milk,
- Hospitalization in NICU (Neonatal Intensive Care Unit),
- Treatment of breastfeeding mother having given birth recently or of the neonate with antibiotics after delivery.
Key Trial Info
Start Date :
August 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 15 2022
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT03320837
Start Date
August 1 2017
End Date
December 15 2022
Last Update
November 22 2023
Active Locations (1)
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1
Aretaieio Hospital
Athens, Attica, Greece, 11528