Formula MilkNCT06052592
Metabolomic Profile in Breastfed Late Preterm Infants
An observational study of Formula Milk and Breast Milk Collection, run by Ospedale Buon Consiglio Fatebenefratelli at 2 sites in Italy.
Trial summary
Exclusive breast milk is recommended from birth to 6 months of life to promote the development of a balanced intestinal microbiota. Human milk provides several bioactive components, from natural probiotics such as Bifidobacterium spp. Read more about this study
- Who is it for?
- Ages 34 to 37 weeks
- Conditions the study is for
- Formula Milk, Breast Milk Collection, Postbiotic Supplemented Formula Milk
- What is being tested?
- Milk
- How many people
- 54 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Mar 2022to 1 Nov 2023
- 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 34 to 37 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Infants born at Ospedale Buon Consiglio Fatebenefratelli, Naples
Who may be able to join
- Weight appropriate to gestational age (percentiles >10th and <90th)
- Written informed consent
Who cannot join
- Cardiological diseases
- Liver disease
- Gastrointestinal diseases with malabsorption
- Endocrinological diseases
- Perinatal infections
- Metabolic and genetic diseases
- Born to mothers with endocrinological and metabolic diseases
- Withdrawal of informed consent
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Department of Woman and Child, Buon Consiglio Fatebenefratelli Hospital
Naples, Napoli, 80123
Department of Pharmacy, University of Salerno
Salerno, Naples, 84084
About this study
Official title: Metabolomic Profile in Breastfed Late Preterm Infants Versus Standard Formula Milk or Postbiotic-supplemented Formula Milk
Exclusive breast milk is recommended from birth to 6 months of life to promote the development of a balanced intestinal microbiota. Human milk provides several bioactive components, from natural probiotics such as Bifidobacterium spp. and Lactobacillus spp., to their metabolites which colonize the intestine of the newborn. However, if breast milk is not available or insufficient, it is used formula milk as a substitute. Infant formula can be supplemented with postbiotics to promote maturation of immune, metabolic and microbial components, similar to breast milk. Postbiotics are preparations composed of both microbial constituents and their metabolites, produced during fermentation.
Read the detailed description
A balanced nutrition starting from early childhood significantly influences growth and psychomotor development. Exclusive breast milk is the recommended nutritional choice from birth to 6 months of life, as it guarantees everything necessary for growth, maturation, protection from infections, promoting the development of a balanced intestinal microbiota. Several prenatal and perinatal factors including the type of delivery, the use of antibiotics, diet and other environmental factors, can influence the microbial colonization of the newborn. Thus, it is generally accepted that the gut microbiota of the healthy, full-term, vaginally born, breastfed infant is the gold standard for a favorable microbial composition in the early years of life. Human milk provides several bioactive components, from natural probiotics such as Bifidobacterium spp. and Lactobacillus spp., to their metabolites ("natural postbiotics"), which colonize the intestine of the newborn. These metabolites regulate the development of the immune system and attenuate the inflammatory processes. However, if breast milk is not available or insufficient to meet the nutritional needs of the infant, formula milk is proposed and used as a substitute. Given the benefits, it is essential that infant formula is as close to human milk as possible, providing bioactive substances that target gut and immune system health. Current research focuses on optimizing artificial formulas, with the aim of resembling human milk in composition and functionality, with some on the market already including probiotics, prebiotics, synbiotics and postbiotics. However, it still remains to be clarified which is the best formulation and the exact consequences on the immune, metabolic and microbial system of the newborn. In particular, postbiotics are preparations composed of both microbial constituents and their metabolites, produced during fermentation. It has already been highlighted in the literature that the enrichment of formula milk with post-biotics would seem to offer advantages for feeding term infants. Furthermore, it promotes an immune, metabolic and microbial component maturation, similarly to human milk, thus making postbiotic supplements very promising and interesting in the nutrition of newborns and infants.
- Being tested
- Milk
- Keywords
- newborn, human milk, formula milk, postbiotic
- Medical subject headings
- Breast Milk Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MilkOther
Newborns will be fed with breast milk, formula milk or postbiotic formula milk
| Study group | Role | What they receive |
|---|---|---|
| Group A | Newborns fed with formula milk supplemented with 20 mg/day of fermented FOS from Lactobacillus paracasei strain CNCM I-5220 and Vitamin D (0.5 ml of SMART D3 MATRIX) Receives: Other: Milk | |
| Group B | Newborns fed with formula milk Receives: Other: Milk | |
| Group C | Newborns fed with exclusive breast milk Receives: Other: Milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of metabolomic profile by liquid chromatography mass spectrometry in breastfed late preterm infants
To detect the differences in the metabolome of the newborns
Measured: 5 days after delivery
Evaluation of metabolomic profile by liquid chromatography mass spectrometry in breastfed late preterm infants
To detect the differences in the metabolome of the newborns
Measured: 1 month after delivery
Evaluation of metabolomic profile by liquid chromatography mass spectrometry in breastfed late preterm infants
To detect the differences in the metabolome of the newborns
Measured: 3 months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start1 Mar 2022
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Formula MilkStudies 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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Buon Consiglio Fatebenefratelli
- Sponsor type
- University, hospital or other
- Collaborators
- University of Salerno
- Responsible party
- Principal investigator, Giuseppe De Bernardo, Ospedale Buon Consiglio Fatebenefratelli
- Investigators
- Giuseppe De Bernardo, MD, Principal investigator, Ospedale Buon Consiglio Fatebenefratelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06052592
- Sponsor's protocol ID
- 1680/CE Lazio 1
- Status last verified
- Aug 2023
- First submitted
- 3 Aug 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolomic Profile in Breastfed Late Preterm Infants Versus Standard Formula Milk or Postbiotic-supplemented Formula Milk
- ClinicalTrials.gov ID
- NCT06052592
- Acronym / sponsor ID
- 1680/CE Lazio 1
- Keywords
- newborn, human milk, formula milk, postbiotic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Ospedale Buon Consiglio FatebenefratelliUniversity, hospital or other
- Collaborators
- University of Salerno
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 25 Sep 2023 (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.
Exclusive breast milk is recommended from birth to 6 months of life to promote the development of a balanced intestinal microbiota. Human milk provides several bioactive components, from natural probiotics such as Bifidobacterium spp. and Lactobacillus spp., to their metabolites which colonize the intestine of the newborn. However, if breast milk is not available or insufficient, it is used formula milk as a substitute. Infant formula can be supplemented with postbiotics to promote maturation of immune, metabolic and microbial components, similar to breast milk. Postbiotics are preparations composed of both microbial constituents and their metabolites, produced during fermentation.
Detailed description
A balanced nutrition starting from early childhood significantly influences growth and psychomotor development. Exclusive breast milk is the recommended nutritional choice from birth to 6 months of life, as it guarantees everything necessary for growth, maturation, protection from infections, promoting the development of a balanced intestinal microbiota. Several prenatal and perinatal factors including the type of delivery, the use of antibiotics, diet and other environmental factors, can influence the microbial colonization of the newborn. Thus, it is generally accepted that the gut microbiota of the healthy, full-term, vaginally born, breastfed infant is the gold standard for a favorable microbial composition in the early years of life. Human milk provides several bioactive components, from natural probiotics such as Bifidobacterium spp. and Lactobacillus spp., to their metabolites ("natural postbiotics"), which colonize the intestine of the newborn. These metabolites regulate the development of the immune system and attenuate the inflammatory processes. However, if breast milk is not available or insufficient to meet the nutritional needs of the infant, formula milk is proposed and used as a substitute. Given the benefits, it is essential that infant formula is as close to human milk as possible, providing bioactive substances that target gut and immune system health. Current research focuses on optimizing artificial formulas, with the aim of resembling human milk in composition and functionality, with some on the market already including probiotics, prebiotics, synbiotics and postbiotics. However, it still remains to be clarified which is the best formulation and the exact consequences on the immune, metabolic and microbial system of the newborn. In particular, postbiotics are preparations composed of both microbial constituents and their metabolites, produced during fermentation. It has already been highlighted in the literature that the enrichment of formula milk with post-biotics would seem to offer advantages for feeding term infants. Furthermore, it promotes an immune, metabolic and microbial component maturation, similarly to human milk, thus making postbiotic supplements very promising and interesting in the nutrition of newborns and infants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Other: MilkNewborns fed with formula milk supplemented with 20 mg/day of fermented FOS from Lactobacillus paracasei strain CNCM I-5220 and Vitamin D (0.5 ml of SMART D3 MATRIX) |
| Group B | – | Other: MilkNewborns fed with formula milk |
| Group C | – | Other: MilkNewborns fed with exclusive breast milk |
Who may qualify
- Ages
- 34 to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants born at Ospedale Buon Consiglio Fatebenefratelli, Naples
Key inclusion criteria (2 listed)
- Weight appropriate to gestational age (percentiles >10th and <90th)
- Written informed consent
Key exclusion criteria (8 listed)
- Cardiological diseases
- Liver disease
- Gastrointestinal diseases with malabsorption
- Endocrinological diseases
- Perinatal infections
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 |
|---|---|---|
| MilkNewborns will be fed with breast milk, formula milk or postbiotic formula milk | Other | Group A, Group B, Group C |
Primary outcome
Evaluation of metabolomic profile by liquid chromatography mass spectrometry in breastfed late preterm infants
Time frame: 5 days after delivery
To detect the differences in the metabolome of the newborns
Evaluation of metabolomic profile by liquid chromatography mass spectrometry in breastfed late preterm infants
Time frame: 1 month after delivery
To detect the differences in the metabolome of the newborns
Evaluation of metabolomic profile by liquid chromatography mass spectrometry in breastfed late preterm infants
Time frame: 3 months after delivery
To detect the differences in the metabolome of the newborns
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 19 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Formula Milk
Recruiting
Evaluation of the Tolerance of a New Formula Based on Hydrolyzed Rice Proteins in Children With Cow's Milk Allergy
IgE-Mediated Cow Milk Allergy
Not yet recruiting
Milk Free From A1-Type β-Casein With Human Milk Oligosaccharides on Gut Health, Immunity, Cognitive Development, and Temperament in Toddlers
Healthy Volunteers
Recruiting
Infant Formula in Infants and Children With Cow's Milk Allergy
Cow's Milk Allergy
Not yet recruiting
TeriFort 1+ Study: Efficacy and Safety of an Extensively Hydrolyzed Formula in the Management of Cow's Milk Protein Allergy in Young Children: A Prospective, Single-Arm Interventional Study (TeriFort 1+)
Cow's Milk Protein Allergy (CMPA)
Not yet recruitingObservational study
Modulen IBD for Induction and Maintenance of Remission in Pediatric Crohn's Disease
Crohn Disease, Inflammatory Bowel Diseases
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.
Giuseppe De Bernardo, MD principal investigator
Ospedale Buon Consiglio Fatebenefratelli
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Formula Milk and Breast Milk Collection, run by Ospedale Buon Consiglio Fatebenefratelli at 2 sites in Italy.
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 2 inclusion and 8 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
Evaluation of metabolomic profile by liquid chromatography mass spectrometry in breastfed late preterm infants (time frame: 5 days after delivery). The study lists 3 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 19 Sep 2024.