Effect of a New Infant Formula With Specific Ingredients

Infant Growth Clinical Trial

— EARLY-TOLERA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04306263
• Other study ID #: EARLY-TOLERA
• Status: Recruiting
• Phase: N/A
• Start date: March 2, 2020
• Est. completion date: September 2022

Study information

• Verified date: December 2020
• Source: Laboratorios Ordesa
• Contact: Roser De Castellar, MD
• Phone: 902 10 52 43
• Email: roser.decastellar[@]ordesa.es
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 231
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 2 Months

Eligibility

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).

Related Conditions & MeSH terms

• Infant Growth

Intervention

Dietary Supplement:
• Enriched infant formula
Infant formula enriched with dairy ingredients: osteopontin, prebiotics and probiotics
• Standard formula
Infants receiving a standard infant formula.
• Breastfeeding arm
Infants exclusively or predominantly breastfed (>75%).

Locations

Country	Name	City	State
Spain	Cristina Campoy	Granada	Andalucia

Sponsors (2)

Lead Sponsor	Collaborator
Laboratorios Ordesa	Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Register of infections	Register of infant infections through patient diaries completed by parents	From baseline to 12 months
Primary	Register of fever episodes	Presence and duration of the fever and treatments, through diaries completed by parents	From baseline to 12 months.
Primary	Register of diarrhea episodes	Presence and duration of diarrhea, registered in patients dairies.	From baseline to 12 months.
Secondary	Immune response evaluation	registration of Immunoglobulin secreted in saliva	At 3, 6 and 12 months of age
Secondary	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.
Secondary	Obstetric background	Relevant obstetric background	Baseline
Secondary	Study of the infant microbiota	Stool bacteria count	At 3, 6 and 12 months.
Secondary	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.
Secondary	Infant neurodevelopment	Analysis of eye movements. Eye tracking technologies is using to assess early cognitive development to evaluate attention domain	At 12 months
Secondary	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.
Secondary	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.
Secondary	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
Secondary	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