Infant GrowthEARLY-TOLERANCT04306263
Effect of a New Infant Formula With Specific Ingredients
A study testing Enriched infant formula, Standard formula and Breastfeeding arm in people with Infant Growth, run by Laboratorios Ordesa at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 2 monthsHealthy volunteers can take part
- Conditions the study is for
- Infant Growth
- What is being tested?
- Enriched infant formula, Standard formula and Breastfeeding arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 231 participants
- Where
- 1 siteSpain
- Study dates
- 2 Mar 2020to Sep 2022
- Phase
- Interventional
- 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 Up to 2 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
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- Additional Inclusion Criteria for groups 1 and 2:
- 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.
- Additional Inclusion Criteria for group 3 (breastfeed infants):
- 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.
Who cannot join
- Simultaneous participation in other clinical trials.
- 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).
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Cristina Campoy
Granada, Andalusia, 18016
Cristina Campoy, MD, +34629308695, ccampoy@ugr.es
About this study
Official title: Evaluation of the Effect of a New Infant Formula With Specific Ingredients on the Development of the Immune System and the Gastrointestinal Health of the Infant
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.
Read the detailed description
Nowadays, almost all commercial infant formulas resemble the "gold standard" of breast milk in terms of composition of essential nutrients, but it is still a challenge to identify and incorporate certain bioactive components capable of replicating those stimuli typical of breast milk that can program growth, infant development and maturation of the immune system.
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
- Infant Growth
- Being tested
- Enriched infant formula, Standard formula, Breastfeeding arm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enriched infant formulaDietary supplement
Infant formula enriched with dairy ingredients: osteopontin, prebiotics and probiotics
Standard formulaDietary supplement
Infants receiving a standard infant formula.
Breastfeeding armDietary supplement
Infants exclusively or predominantly breastfed (>75%).
| Study group | Role | What they receive |
|---|---|---|
| Enriched infant formula | Experimental | Infant formula enriched with dairy ingredients: osteopontin, prebiotics (Human milk oligosaccharide, Glucooligosaccharides) and probiotics. Receives: Dietary Supplement: Enriched infant formula |
| Standard formula | Active comparator | Infants receiving a standard infant formula. Receives: Dietary Supplement: Standard formula |
| Breastfeeding arm | Active comparator | Infants exclusively or predominantly breastfed (>75%). Receives: Dietary Supplement: Breastfeeding arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Register of infections
Register of infant infections through patient diaries completed by parents
Measured: From baseline to 12 months
Register of fever episodes
Presence and duration of the fever and treatments, through diaries completed by parents
Measured: From baseline to 12 months.
Register of diarrhea episodes
Presence and duration of diarrhea, registered in patients dairies.
Measured: From baseline to 12 months.
Secondary outcomes (10)
Immune response evaluation
registration of Immunoglobulin secreted in saliva
Measured: At 3, 6 and 12 months of age
Demographic data
age of the parents, educational level of the parents, habits and lifestyles of the parents, residence and social environment of the infant.
Measured: From baseline to 12 months.
Obstetric background
Relevant obstetric background
Measured: Baseline
Study of the infant microbiota
Stool bacteria count
Measured: At 3, 6 and 12 months.
Assessment of normal growth of the infant
Evolution of Weight (g), Size (cm) to calculate the Body Mass Index.weight and height will be combined to report BMI in kg/m^2
Measured: From baseline to 12 months.
Infant neurodevelopment
Analysis of eye movements. Eye tracking technologies is using to assess early cognitive development to evaluate attention domain
Measured: At 12 months
Infant neurodevelopment 2
ASQ-3 (Ages \& Stages Questionnaires®) ASQ-3 is a set of questionnaires about children's development
Measured: At 2, 3, 4, 6, 9 and 12 months of age.
Infant neurodevelopment 3
General Movements test (GM´s) GM's is using for the neurological assessment during the first months of life and measures a series of gross movements of variable amplitude and speed involving all body parts
Measured: At 2, 3 and 4 months of life.
Infant neurodevelopment 4
Bayley´s Scales of Infant Development III (Spanish version BSID III) is using to evaluate psychomotor and mental development .
Measured: 6 and 12 months of age
Infant neurodevelopment 5
MacArthur Communicative Development Inventory (CDI) . This test assesses the normal process of early language acquisition by various manifestations
Measured: 12 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start2 Mar 2020
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant GrowthStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 231 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratorios Ordesa
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universidad de Granada
- Responsible party
- Sponsor
- Investigators
- Cristina Campoy, MD, Principal investigator, EURISTIKOS Excellence Centre for Paediatric Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04306263
- Sponsor's protocol ID
- EARLY-TOLERA
- Acronym
- EARLY-TOLERA
- Status last verified
- Dec 2020
- First submitted
- 2 Mar 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of a New Infant Formula With Specific Ingredients on the Development of the Immune System and the Gastrointestinal Health of the Infant
- ClinicalTrials.gov ID
- NCT04306263
- Acronym / sponsor ID
- EARLY-TOLERA / EARLY-TOLERA
- Conditions
- Infant Growth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 231 participants (estimated)
- Lead sponsor
- Laboratorios OrdesaIndustry (pharma, biotech, devices)
- Collaborators
- Universidad de Granada
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 12 Mar 2020 (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 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.
Detailed description
Nowadays, almost all commercial infant formulas resemble the "gold standard" of breast milk in terms of composition of essential nutrients, but it is still a challenge to identify and incorporate certain bioactive components capable of replicating those stimuli typical of breast milk that can program growth, infant development and maturation of the immune system.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Enriched infant formula | Experimental | Dietary Supplement: Enriched infant formulaInfant formula enriched with dairy ingredients: osteopontin, prebiotics (Human milk oligosaccharide, Glucooligosaccharides) and probiotics. |
| Standard formula | Active comparator | Dietary Supplement: Standard formulaInfants receiving a standard infant formula. |
| Breastfeeding arm | Active comparator | Dietary Supplement: Breastfeeding armInfants exclusively or predominantly breastfed (>75%). |
Who may qualify
- Ages
- Up to 2 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (5 listed)
- Simultaneous participation in other clinical trials.
- 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).
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 |
|---|---|---|
| Enriched infant formulaInfant formula enriched with dairy ingredients: osteopontin, prebiotics and probiotics | Dietary supplement | Enriched infant formula |
| Standard formulaInfants receiving a standard infant formula. | Dietary supplement | Standard formula |
| Breastfeeding armInfants exclusively or predominantly breastfed (>75%). | Dietary supplement | Breastfeeding arm |
Primary outcome
Register of infections
Time frame: From baseline to 12 months
Register of infant infections through patient diaries completed by parents
Register of fever episodes
Time frame: From baseline to 12 months.
Presence and duration of the fever and treatments, through diaries completed by parents
Register of diarrhea episodes
Time frame: From baseline to 12 months.
Presence and duration of diarrhea, registered in patients dairies.
10 secondary outcomes
Immune response evaluation
Time frame: At 3, 6 and 12 months of age
Demographic data
Time frame: From baseline to 12 months.
Obstetric background
Time frame: Baseline
Study of the infant microbiota
Time frame: At 3, 6 and 12 months.
Assessment of normal growth of the infant
Time frame: From baseline to 12 months.
Infant neurodevelopment
Time frame: At 12 months
Infant neurodevelopment 2
Time frame: At 2, 3, 4, 6, 9 and 12 months of age.
Infant neurodevelopment 3
Time frame: At 2, 3 and 4 months of life.
Infant neurodevelopment 4
Time frame: 6 and 12 months of age
Infant neurodevelopment 5
Time frame: 12 months of age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
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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.
Cristina Campoy, MD principal investigator
EURISTIKOS Excellence Centre for Paediatric Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enriched infant formula, Standard formula and Breastfeeding arm in people with Infant Growth, run by Laboratorios Ordesa at 1 site in Spain.
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 11 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 17 Dec 2020. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roser De Castellar, MD (902 10 52 43, roser.decastellar@ordesa.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Register of infections (time frame: From baseline to 12 months). 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 17 Dec 2020.