Metabolomic Profile of Urine Samples From Neonates Fed With Breast Milk and an Infant Formula Enriched With Synbiotics
Condition: Infant Development
Study type: Observational

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.
    

Intervention name(s): Infant formula; Breast milk
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Breast milk substitute containing synbiotics; Breast milk
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Neonates
      
Biospecimen description: 
      urine samples
    
Keywords: metabolomics; microbiome; infant formula; synbiotics; urine samples; NMR analysis