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 @ 4:14 PM
Ignite Modification Date:
2025-12-24 @ 4:14 PM
NCT ID:
NCT01109966
Eligibility Criteria:
Inclusion Criteria:
* Infants ≤ 8 months of age
* Infants sensitised to cow's milk and diagnosed with IgE mediated cow's milk allergy confirmed by milk challenge or diagnosis of anaphylaxis to milk within the last 3 months
Exclusion Criteria:
* Infants less than 2500 g at birth
* Infants less than 37 weeks gestation
* Infants with severe concurrent illness
* Use of anti- histamines, systemic corticosteroids, systemic antibiotics or anti-mycotic drugs, and immuno-modulatory drugs
* Infants consuming less than 500ml per day of their usual formula at study entry
* Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
8 Months
Study:
NCT01109966
Study Brief:
Protocol Section:
NCT01109966