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 @ 12:22 PM
Ignite Modification Date:
2025-12-24 @ 12:22 PM
NCT ID:
NCT01909661
Eligibility Criteria:
Inclusion Criteria:
* Full term healthy newborns (37-42 Weeks gestation)
* Weight at birth ≥ 2500 g
* Aged between birth to 9 months
* Symptoms of allergy (Skin or digetive)
* Suspicion of cow milk protein allergy
* Infants whose parents/caregivers/legal guardians have the ability to understand and comply with the requirements of the study
* Infants whose parents/caregivers/legal guardians gave their written informed consent to the infant's participation in the study
Exclusion Criteria:
* Children who have returned to breastfeeding
* Presence of any condition, that, in the opinion of the investigator is a contra-indication to the particpation of the infant in the study
* In the past 15 days, treatment or medication likely to :
* induce confusion in the allergy tets (ex. : Skin Prick Test) and / or
* mask the symptoms of an allergic reaction (Anti-allergy medications ; anti-histaminic, anti-leucotrienes, corticosteroids, …)
* Newbonrs presenting a chronic or a genetic malformation, or a chromosomal or other disease, that in the opinion of the investigator could mask the study results
* Children who show signs of malnutrition, or prolonged diarrhea
* Children whose parents show no willingness to comply with study requirements
* Consumption of soya protein based, hydrolyzed protein or elemental (amino acid) formula for more than 21 days before inclusion, unless the skin prick test to cow's milk protein is positive, and the IgE level indicates the existence of IgE mediated allergy to cow's milk protein.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
9 Months
Study:
NCT01909661
Study Brief:
Protocol Section:
NCT01909661