Clinical trial NCT04306263: Effect of a New Infant Formula With Specific Ingredients
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infant Growth
Lead sponsor: Laboratorios Ordesa
Sponsor class: INDUSTRY
Collaborators: name: Universidad de Granada
First posted: 2020-03-12
Enrollment: 231
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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).

Primary outcomes:
measure: Register of infections
timeFrame: From baseline to 12 months
measure: Register of fever episodes
timeFrame: From baseline to 12 months.
measure: Register of diarrhea episodes
timeFrame: From baseline to 12 months.
Secondary outcomes:
measure: Immune response evaluation
timeFrame: At 3, 6 and 12 months of age
measure: Demographic data
timeFrame: From baseline to 12 months.
measure: Obstetric background
timeFrame: Baseline
measure: Study of the infant microbiota
timeFrame: At 3, 6 and 12 months.
measure: Assessment of normal growth of the infant
timeFrame: From baseline to 12 months.
measure: Infant neurodevelopment
timeFrame: At 12 months
measure: Infant neurodevelopment 2
timeFrame: At 2, 3, 4, 6, 9 and 12 months of age.
measure: Infant neurodevelopment 3
timeFrame: At 2, 3 and 4 months of life.
measure: Infant neurodevelopment 4
timeFrame: 6 and 12 months of age
measure: Infant neurodevelopment 5
timeFrame: 12 months of age
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Cristina Campoy
state: Andalucia
Study officials:
affiliation: EURISTIKOS Excellence Centre for Paediatric Research
name: Cristina Campoy, MD
role: PRINCIPAL_INVESTIGATOR
References: