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

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

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.

Study Overview

• Status: Completed
• Conditions: Infant Development
• Intervention / Treatment: Other: Breast milk; Dietary supplement: 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.

• Study Type: Observational
• Enrollment (Actual): 108

Contacts and Locations

Study Locations

• Greece
  • Attiki
    • Athens, Attiki, Greece, 11528
      • Aretaieio Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 4 weeks (Child)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Neonates

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Breastfeeding group; Infant are exclusively fed with breast milk	Other: Breast milk; Breast milk
Mixed feeding group; Infants are fed with mixed nutrition with breast milk and Rontamil Complete 1®	Other: Breast milk; Breast milk; Dietary supplement: Infant formula; Breast milk substitute containing synbiotics
Infant formula group; Infant are fed exclusively with Rontamil Complete 1®	Dietary supplement: Infant formula; Breast milk substitute containing synbiotics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabolomic profile of urine samples	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.	Newborn's age of 2 days
Metabolomic profile of urine samples	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.	Newborn's age of 15 days
Metabolomic profile of urine samples	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.	Newborn's age of 2 months
Metabolomic profile of urine samples	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.	Newborn's age of 3 months

Collaborators and Investigators

• Sponsor: Rontis Hellas SA
• Collaborators: National and Kapodistrian University of Athens; National Hellenic Research Foundation
• Investigators: Study Director: Nicoletta Iacovidou, PhD, National and Kapodistrian University of Athens

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): April 29, 2022
• Study Completion (Actual): December 15, 2022

Study Registration Dates

• First Submitted: October 13, 2017
• First Submitted That Met QC Criteria: October 20, 2017
• First Posted (Actual): October 25, 2017

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: microbiome; metabolomics; infant formula; synbiotics; urine samples; NMR analysis
• Other Study ID Numbers: metabolomicsurinesynbio3x36nmr

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No