Ignite Creation Date:
2024-05-06 @ 10:42 AM
Last Modification Date:
2024-10-26 @ 12:33 PM
Study NCT ID:
NCT03320837
Status:
COMPLETED
Last Update Posted:
2023-11-22
First Post:
2017-10-13
Brief Title:
Metabolomic Profile of Urine Samples From Neonates Fed With Breast Milk and an Infant Formula Enriched With Synbiotics
Sponsor:
Rontis Hellas SA
Organization:
Rontis Hellas SA
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
mtburnIFsynb
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 Blactis 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 ie between 11th and 89th percentile AGA- appropriate for gestational age The mothers 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 andor 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 newborns 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 infants 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 LCMS This urine collection gives reliable results and can be used in infants without causing any discomfort or side-effect
Exclusion criteria insufficient weight gain andor 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 newborns 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 infants 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 LCMS This urine collection gives reliable results and can be used in infants without causing any discomfort or side-effect
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None