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

NCT03320837 | Completed

• 1 other identifier: metabolomicsurinesynbio3x36nmr
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant Development

Keywords

metabolomics; microbiome; infant formula; synbiotics; urine samples; NMR analysis

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

Breastfeeding group

Infant are exclusively fed with breast milk

Other: Breast milk

Mixed feeding group

Infants are fed with mixed nutrition with breast milk and Rontamil Complete 1®

Dietary Supplement: Infant formula; Other: Breast milk

Infant formula group

Infant are fed exclusively with Rontamil Complete 1®

Dietary Supplement: Infant formula

Interventions

Infant formula DIETARY_SUPPLEMENT

Breast milk substitute containing synbiotics

Infant formula group; Mixed feeding group

Breast milk OTHER

Breast milk

Breastfeeding group; Mixed feeding group

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Neonates

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rontis Hellas SA: lead
• National and Kapodistrian University of Athens: collaborator
• National Hellenic Research Foundation: collaborator

Study Sites (1)

Aretaieio Hospital

Athens, Attica, 11528, Greece

Location

Biospecimen

Retention: SAMPLES WITH DNA

urine samples

MeSH Terms

Interventions

Infant Formula; Milk, Human

Intervention Hierarchy (Ancestors)

Milk Substitutes; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food, Formulated; Foods, Specialized; Food; Infant Food; Food and Beverages; Milk; Dairy Products

Study Officials

• Nicoletta Iacovidou, PhD

  National and Kapodistrian University of Athens

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2017
• First Posted: October 25, 2017
• Study Start: August 1, 2017
• Primary Completion: April 29, 2022
• Study Completion: December 15, 2022
• Last Updated: November 22, 2023

Record last verified: 2023-11

Locations

GR (1)