Effect of a New Infant Formula With Specific Ingredients

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Infant Growth

Intervention / Treatment
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* Dietary Supplement: Enriched infant formula
* Dietary Supplement: Standard formula
* Dietary Supplement: Breastfeeding arm


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Maximum Age: 2 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enriched infant formula<br>Infant formula enriched with dairy ingredients: osteopontin, prebiotics (Human milk oligosaccharide, Glucooligosaccharides) and probiotics. | Dietary Supplement: Enriched infant formula<br>* Infant formula enriched with dairy ingredients: osteopontin, prebiotics and probiotics<br>|
| Active Comparator: Standard formula<br>Infants receiving a standard infant formula. | Dietary Supplement: Standard formula<br>* Infants receiving a standard infant formula.<br>|
| Active Comparator: Breastfeeding arm<br>Infants exclusively or predominantly breastfed (>75%). | Dietary Supplement: Breastfeeding arm<br>* Infants exclusively or predominantly breastfed (>75%).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Register of infections | Register of infant infections through patient diaries completed by parents | From baseline to 12 months | 
| Register of fever episodes | Presence and duration of the fever and treatments, through diaries completed by parents | From baseline to 12 months. | 
| Register of diarrhea episodes | Presence and duration of diarrhea, registered in patients dairies. | From baseline to 12 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immune response evaluation | registration of Immunoglobulin secreted in saliva | 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. | From baseline to 12 months. | 
| Obstetric background | Relevant obstetric background | Baseline | 
| Study of the infant microbiota | Stool bacteria count | 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 | 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 | At 12 months | 
| Infant neurodevelopment 2 | ASQ-3 (Ages & Stages Questionnaires®) ASQ-3 is a set of questionnaires about children's development | 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 | 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 . | 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 | 12 months of age |