EARLY-TOLERA: Effect of a New Infant Formula With Specific Ingredients
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Enriched infant formula Infant formula enriched with dairy ingredients: osteopontin, prebiotics (Human milk oligosaccharide, Glucooligosaccharides) and probiotics. |
Dietary Supplement: Enriched infant formula
Infant formula enriched with dairy ingredients: osteopontin, prebiotics and probiotics
|
| Active Comparator: Standard formula Infants receiving a standard infant formula. |
Dietary Supplement: Standard formula
Infants receiving a standard infant formula.
|
| Active Comparator: Breastfeeding arm Infants exclusively or predominantly breastfed (>75%). |
Dietary Supplement: Breastfeeding arm
Infants exclusively or predominantly breastfed (>75%).
|
Outcome Measures
Primary Outcome Measures
- Register of infections [From baseline to 12 months]
Register of infant infections through patient diaries completed by parents
- Register of fever episodes [From baseline to 12 months.]
Presence and duration of the fever and treatments, through diaries completed by parents
- Register of diarrhea episodes [From baseline to 12 months.]
Presence and duration of diarrhea, registered in patients dairies.
Secondary Outcome Measures
- Immune response evaluation [At 3, 6 and 12 months of age]
registration of Immunoglobulin secreted in saliva
- Demographic data [From baseline to 12 months.]
age of the parents, educational level of the parents, habits and lifestyles of the parents, residence and social environment of the infant.
- Obstetric background [Baseline]
Relevant obstetric background
- Study of the infant microbiota [At 3, 6 and 12 months.]
Stool bacteria count
- Assessment of normal growth of the infant [From baseline to 12 months.]
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
- Infant neurodevelopment [At 12 months]
Analysis of eye movements. Eye tracking technologies is using to assess early cognitive development to evaluate attention domain
- Infant neurodevelopment 2 [At 2, 3, 4, 6, 9 and 12 months of age.]
ASQ-3 (Ages & Stages Questionnaires®) ASQ-3 is a set of questionnaires about children's development
- Infant neurodevelopment 3 [At 2, 3 and 4 months of life.]
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
- Infant neurodevelopment 4 [6 and 12 months of age]
Bayley´s Scales of Infant Development III (Spanish version BSID III) is using to evaluate psychomotor and mental development .
- Infant neurodevelopment 5 [12 months of age]
MacArthur Communicative Development Inventory (CDI) . This test assesses the normal process of early language acquisition by various manifestations
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Inclusion age from 0 to 2.5 months of age.
-
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
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.
Exclusion Criteria:
-
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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cristina Campoy | Granada | Andalucia | Spain | 18016 |
Sponsors and Collaborators
- Laboratorios Ordesa
- Universidad de Granada
Investigators
- Principal Investigator: Cristina Campoy, MD, EURISTIKOS Excellence Centre for Paediatric Research
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EARLY-TOLERA