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

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ClinicalTrials.gov Identifier: NCT03320837
Recruitment Status : Recruiting
First Posted : October 25, 2017
Last Update Posted : October 25, 2017
Sponsor:
Collaborators:
National and Kapodistrian University of Athens
National Hellenic Research Foundation
Information provided by (Responsible Party):
Rontis Hellas SA

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.

Condition or disease Intervention/treatment
Infant Development Dietary Supplement: Infant formula Other: Breast milk

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
Estimated Enrollment : 108 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


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®
Dietary Supplement: Infant formula
Breast milk substitute containing synbiotics

Other: Breast milk
Breast milk

Infant formula group
Infant are fed exclusively with Rontamil Complete 1®
Dietary Supplement: Infant formula
Breast milk substitute containing synbiotics




Primary Outcome Measures :
  1. Metabolomic profile of urine samples [ Time Frame: Newborn's age of 2 days ]
    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.

  2. Metabolomic profile of urine samples [ Time Frame: Newborn's age of 15 days ]
    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.

  3. Metabolomic profile of urine samples [ Time Frame: Newborn's age of 2 months ]
    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.

  4. Metabolomic profile of urine samples [ Time Frame: Newborn's age of 3 months ]
    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.


Biospecimen Retention:   Samples With DNA
urine samples


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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Neonates
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03320837


Contacts
Contact: Apostolos Karoutis, MSc +302103447600 ext 707 apostolos.karoutis@rontis.com

Locations
Greece
Aretaieio Hospital Recruiting
Athens, Attiki, Greece, 11528
Contact: Nicoletta Iacovidou, PhD    +306932400834    niciac58@gmail.com   
Contact: Theodora Boutsikou, PhD    +302107286000    theobtsk@gmail.com   
Sponsors and Collaborators
Rontis Hellas SA
National and Kapodistrian University of Athens
National Hellenic Research Foundation
Investigators
Study Director: Nicoletta Iacovidou, PhD National and Kapodistrian University of Athens

Responsible Party: Rontis Hellas SA
ClinicalTrials.gov Identifier: NCT03320837     History of Changes
Other Study ID Numbers: metabolomicsurinesynbio3x36nmr
First Posted: October 25, 2017    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rontis Hellas SA:
metabolomics
microbiome
infant formula
synbiotics
urine samples
NMR analysis