Metabolomic Profile of Urine Samples From Neonates Fed With Breast Milk and an Infant Formula Enriched With Synbiotics
NCT ID: NCT03320837
Last Updated: 2023-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
108 participants
OBSERVATIONAL
2017-08-01
2022-12-15
Brief Summary
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Detailed Description
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Exclusion criteria: 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.
Method: 36 Infants in exclusive breastfeeding, 36 infants feeding exclusively on infant formula with synbiotics and 36 infants following mixed nutrition with breast milk and infant formula with synbiotics, for a period of 3 months have been selected on randomized basis. For all these three groups, the anthropometric parameters should be measured (length, weight, head perimeter), since the first day of newborn's inclusion in the trial and at the age of 15 days, 2 and 3 months. Moreover, at the age of 15 days, 2 months, 3 months and on the infant's inclusion day in the trial, newborns-infants urine sample should be collected by the attending doctor using a ball of cotton inserted into the disposable diaper and with the aid of an aspiration syringe the urine sample (2-3 ml) will be transferred to a sterile vial and finally stored at -80 °C. Then frozen urine samples will be sent in batches to a contracted diagnostic center in order to examine the metabolic profile of the three diets described above (exclusive breastfeeding, infant formula with synbiotics and mixed nutrition with breast milk and infant formula with synbiotics), with the help of NMR and selectively liquid chromatography /mass spectrometry (LC/MS). This urine collection gives reliable results and can be used in infants without causing any discomfort or side-effect.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Breastfeeding group
Infant are exclusively fed with breast milk
Breast milk
Breast milk
Mixed feeding group
Infants are fed with mixed nutrition with breast milk and Rontamil Complete 1®
Infant formula
Breast milk substitute containing synbiotics
Breast milk
Breast milk
Infant formula group
Infant are fed exclusively with Rontamil Complete 1®
Infant formula
Breast milk substitute containing synbiotics
Interventions
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Infant formula
Breast milk substitute containing synbiotics
Breast milk
Breast milk
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* Hospitalization in NICU (Neonatal Intensive Care Unit),
* Treatment of breastfeeding mother having given birth recently or of the neonate with antibiotics after delivery.
1 Day
28 Days
ALL
Yes
Sponsors
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National and Kapodistrian University of Athens
OTHER
National Hellenic Research Foundation
OTHER
Rontis Hellas SA
INDUSTRY
Responsible Party
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Principal Investigators
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Nicoletta Iacovidou, PhD
Role: STUDY_DIRECTOR
National and Kapodistrian University of Athens
Locations
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Aretaieio Hospital
Athens, Attica, Greece
Countries
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Other Identifiers
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metabolomicsurinesynbio3x36nmr
Identifier Type: -
Identifier Source: org_study_id