Clinical trial NCT03320837: Metabolomic Profile of Urine Samples From Neonates Fed With Breast Milk and an Infant Formula Enriched With Synbiotics
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant Development
Keywords: metabolomics
microbiome
infant formula
synbiotics
urine samples
NMR analysis
Lead sponsor: Rontis Hellas SA
Sponsor class: INDUSTRY
Collaborators: name: National and Kapodistrian University of Athens
name: National Hellenic Research Foundation
First posted: 2017-10-25
Enrollment: 108
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Neonates

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 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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Metabolomic profile of urine samples
timeFrame: Newborn's age of 2 days
measure: Metabolomic profile of urine samples
timeFrame: Newborn's age of 15 days
measure: Metabolomic profile of urine samples
timeFrame: Newborn's age of 2 months
measure: Metabolomic profile of urine samples
timeFrame: Newborn's age of 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Aretaieio Hospital
state: Attiki
Study officials:
affiliation: National and Kapodistrian University of Athens
name: Nicoletta Iacovidou, PhD
role: STUDY_DIRECTOR
References: