Infant DevelopmentmtburnIFsynbNCT03320837
Metabolomic Profile of Urine Samples From Neonates Fed With Breast Milk and an Infant Formula Enriched With Synbiotics
An observational study of Infant Development, run by Rontis Hellas SA at 1 site in Greece.
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… Read more about this study
- Who is it for?
- Ages 1 day to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Infant Development
- What is being tested?
- Infant formula and Breast milk
- How many people
- 108 participants
- Where
- 1 siteGreece
- Study dates
- 1 Aug 2017to 15 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Neonates
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Infant Development
- Being tested
- Infant formula, Breast milk
- Keywords
- metabolomics, microbiome, infant formula, synbiotics, urine samples, NMR analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant formulaDietary supplement
Breast milk substitute containing synbiotics
Breast milkOther
Breast milk
| Study group | Role | What they receive |
|---|---|---|
| Breastfeeding group | Infant are exclusively fed with breast milk Receives: Other: Breast milk | |
| Mixed feeding group | Infants are fed with mixed nutrition with breast milk and Rontamil Complete 1® Receives: Dietary Supplement: Infant formula; Other: Breast milk | |
| Infant formula group | Infant are fed exclusively with Rontamil Complete 1® Receives: Dietary Supplement: Infant formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Newborn's age of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start1 Aug 2017
- Primary completion29 Apr 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rontis Hellas SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National and Kapodistrian University of Athens, National Hellenic Research Foundation
- Responsible party
- Sponsor
- Investigators
- Nicoletta Iacovidou, PhD, Study director, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03320837
- Sponsor's protocol ID
- metabolomicsurinesynbio3x36nmr
- Acronym
- mtburnIFsynb
- Status last verified
- Nov 2023
- First submitted
- 13 Oct 2017
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03320837
- Acronym / sponsor ID
- mtburnIFsynb / metabolomicsurinesynbio3x36nmr
- Conditions
- Infant Development
- Keywords
- metabolomics, microbiome, infant formula, synbiotics, urine samples, NMR analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Rontis Hellas SAIndustry (pharma, biotech, devices)
- Collaborators
- National and Kapodistrian University of Athens, National Hellenic Research Foundation
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 29 Apr 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 25 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Breastfeeding group | – | Other: Breast milkInfant are exclusively fed with breast milk |
| Mixed feeding group | – | Dietary Supplement: Infant formula, Other: Breast milkInfants are fed with mixed nutrition with breast milk and Rontamil Complete 1® |
| Infant formula group | – | Dietary Supplement: Infant formulaInfant are fed exclusively with Rontamil Complete 1® |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Neonates
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infant formulaBreast milk substitute containing synbiotics | Dietary supplement | Infant formula group, Mixed feeding group |
| Breast milkBreast milk | Other | Breastfeeding group, Mixed feeding group |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicoletta Iacovidou, PhD study director
National and Kapodistrian University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant Development, run by Rontis Hellas SA at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolomic profile of urine samples (time frame: Newborn's age of 2 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.