Skip to main content
OpenTrials
Completed

NCT Number: NCT03320837

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Infant Development

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Aretaieio Hospital

Athens, Attica, 11528, Greece

About this study

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). The mother's medical history should be free of any chronic diseases and allergies, while the gestation history should be free of any complications and of any pharmaceutical treatment administration prior to delivery.

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 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.

Treatment and study plan

Infant Formula

Dietary Supplement

Breast milk substitute containing synbiotics

breast milk

Other

Breast milk

Primary outcomes

  1. Metabolomic profile of urine samples

    Time frame: Newborn's age of 2 days

    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, Rontamil Complete 1® and mixed nutrition with breast milk and Rontamil Complete 1®), 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.

  2. Metabolomic profile of urine samples

    Time frame: Newborn's age of 15 days

    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, Rontamil Complete 1® and mixed nutrition with breast milk and Rontamil Complete 1®), 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.

  3. Metabolomic profile of urine samples

    Time frame: Newborn's age of 2 months

    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, Rontamil Complete 1® and mixed nutrition with breast milk and Rontamil Complete 1®), 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.

  4. Metabolomic profile of urine samples

    Time frame: Newborn's age of 3 months

    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, Rontamil Complete 1® and mixed nutrition with breast milk and Rontamil Complete 1®), 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.

Sponsors and collaborators

Lead sponsor

Rontis Hellas SA

Industry

Collaborators

  • National Hellenic Research Foundation
  • National and Kapodistrian University of Athens

Registry information

Official study title

Metabolomic Profile of Urine Samples From Neonates Fed Exclusively With Breast Milk as Compared With the Profile of Neonates Fed With an Infant Formula Enriched With Synbiotics

Acronym: mtburnIFsynb

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Oct 25, 2017
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.