Effect of a New Infant Formula With Specific Ingredients
NCT ID: NCT04306263
Last Updated: 2020-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
231 participants
INTERVENTIONAL
2020-03-02
2022-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The purpose of this study is to test whether the addition of certain bioactive ingredients to a new infant formula (HMOs, osteopontin and probiotics) can have a favorable impact on the development of the infant's immune system in the first months of life.
In addition, considering that the quality of feeding at these early ages will program (Early programming) the health and physiology of the child and the future adult, the study wants to obtain evidence of the effects of this new infant formula on the immune system and the development of the child compared to breast milk during the first year of life, hoping that it promotes proper growth, adequate cognitive development and maturation of the immune system as similar as possible to children fed to the mother's breast.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Enriched infant formula
Infant formula enriched with dairy ingredients: osteopontin, prebiotics (Human milk oligosaccharide, Glucooligosaccharides) and probiotics.
Enriched infant formula
Infant formula enriched with dairy ingredients: osteopontin, prebiotics and probiotics
Standard formula
Infants receiving a standard infant formula.
Standard formula
Infants receiving a standard infant formula.
Breastfeeding arm
Infants exclusively or predominantly breastfed (\>75%).
Breastfeeding arm
Infants exclusively or predominantly breastfed (\>75%).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Enriched infant formula
Infant formula enriched with dairy ingredients: osteopontin, prebiotics and probiotics
Standard formula
Infants receiving a standard infant formula.
Breastfeeding arm
Infants exclusively or predominantly breastfed (\>75%).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Gestational age \>37 weeks and \<41 weeks inclusive.
* Appropriate birth weight appropriate for your gestational age (between 10-90 percentiles).
* APGAR score normal birth to 1' and 5' of 7 - 10.
* Umbilical pH ≥ 7.10.
* Availability to continue throughout the study period.
* Written informed consent
* Infants who, at the time of recruitment, have already passed the diet with a majority or exclusive formula for medical reasons, by decision of the parents or any other reason agreed with the pediatrician.
* Infants who have been breastfed until the second month with exclusive or majority breastfeeding.
* Infants who are expected to be exclusively or predominantly breastfed up to 6 months.
Exclusion Criteria
* Infants suffering from gastrointestinal disorders (allergy and/or intolerance to cow's milk protein or lactose).
* Mother's pathology history and during gestation: neurological diseases, metabolic disorders, type 1 diabetes mellitus, chronic disease (hypothyroidism), maternal malnutrition, TORCH syndrome.
* Treatment of the mother's anxiolytics or antidepressants. Other treatments with drugs potentially harmful to neurodevelopment.
* Inability of the parents to follow up the study (medical decision).
2 Months
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Universidad de Granada
OTHER
Laboratorios Ordesa
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Cristina Campoy, MD
Role: PRINCIPAL_INVESTIGATOR
EURISTIKOS Excellence Centre for Paediatric Research
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cristina Campoy
Granada, Andalusia, Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Cristina Campoy, MD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EARLY-TOLERA
Identifier Type: -
Identifier Source: org_study_id