Effect of a New Infant Formula With Specific Ingredients (EARLY-TOLERA)

Laboratorios Ordesa

Status: Unknown

Conditions: Infant Growth

Treatments: Dietary Supplement: Standard formula; Dietary Supplement: Breastfeeding arm; Dietary Supplement: Enriched infant formula

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04306263

EARLY-TOLERA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 231 estimated patients

Sex: All

Ages: Under 2 months old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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231 participants in 3 patient groups

Enriched infant formula

Experimental group

Description:

Infant formula enriched with dairy ingredients: osteopontin, prebiotics (Human milk oligosaccharide, Glucooligosaccharides) and probiotics.

Treatment:

Dietary Supplement: Enriched infant formula

Standard formula

Active Comparator group

Description:

Infants receiving a standard infant formula.

Treatment:

Dietary Supplement: Standard formula

Breastfeeding arm

Active Comparator group

Description:

Infants exclusively or predominantly breastfed (\>75%).

Treatment:

Dietary Supplement: Breastfeeding arm