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

Infant Development Clinical Trial

— mtburnIFsynb  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03320837
• Other study ID #: metabolomicsurinesynbio3x36nmr
• Status: Completed
• Start date: August 1, 2017
• Est. completion date: December 15, 2022

Study information

• Verified date: November 2023
• Source: Rontis Hellas SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: December 15, 2022
• Est. primary completion date: April 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 28 Days

Eligibility

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.

Related Conditions & MeSH terms

• Infant Development

Intervention

Dietary Supplement:
• Infant formula
Breast milk substitute containing synbiotics

Other:
• Breast milk
Breast milk

Locations

Country	Name	City	State
Greece	Aretaieio Hospital	Athens	Attiki

Sponsors (3)

Lead Sponsor	Collaborator
Rontis Hellas SA	National and Kapodistrian University of Athens, National Hellenic Research Foundation

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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