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

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

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.

Study Overview

• Status: Unknown
• Conditions: Infant Growth
• Intervention / Treatment: Dietary supplement: Enriched infant formula; Dietary supplement: Standard formula; Dietary supplement: Breastfeeding arm

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 Type: Interventional
• Enrollment (Anticipated): 231
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Andalucia
    • Granada, Andalucia, Spain, 18016
      • Recruiting
      • Cristina Campoy
      • Contact: Cristina Campoy, MD; Phone Number: +34629308695; Email: ccampoy@ugr.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / 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%).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Laboratorios Ordesa
• Collaborators: Universidad de Granada
• Investigators: Principal Investigator: Cristina Campoy, MD, EURISTIKOS Excellence Centre for Paediatric Research

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2020
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: March 2, 2020
• First Submitted That Met QC Criteria: March 10, 2020
• First Posted (Actual): March 12, 2020

Study Record Updates

• Last Update Posted (Actual): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 14, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: EARLY-TOLERA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No