Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-24 @ 11:04 PM
NCT ID:
NCT02359669
Eligibility Criteria:
Inclusion Criteria:
* Male or Female children, age 3;0-4;11 years
* Having obtained their legal representative's informed consent
* Level of stimulation in their home environment score below 26 in HOME inventory
* Normal cognitive development
Exclusion Criteria:
* Neurological disorders
* Food allergies (especially milk and soy allergy)
* Documented lactose intolerance
* Children with special nutritional needs
* Children under chronic (more than 7 consecutive days) medications which may impact cognitive performance
* Children not living in a family/children in foster homes
* Subject who cannot be expected to comply with study procedures
* Currently participating or having participated in another clinical study during the last 4 weeks prior to the beginning of this study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
36 Months
Maximum Age:
59 Months
Study:
NCT02359669
Study Brief:
Protocol Section:
NCT02359669