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 @ 9:26 PM
Ignite Modification Date:
2025-12-24 @ 9:26 PM
NCT ID:
NCT00224432
Eligibility Criteria:
Inclusion Criteria:
* Term infants fulfilling the Hanifin (1989) criteria for atopic dermatitis
* Suggestive of CMA (one additional symptom)
* Scorad index (total) \>20 at study entry
* Below 5 months of age
* Formula, not breast fed
* Written informed consent from the parents
Exclusion Criteria:
* • Previous or current use of anti-histamines, oral corticosteroids, probiotics
* Use of systemic antibiotic or anti-mycotic drugs in the previous 4 weeks
* Congenital intestinal abnormality (eg. Hirschsprung's disease, intestinal atresia)
* Other GI disease with intestinal inflammation and/or increased intestinal permeability
* Skin disorder, not atopic dermatitis
* Participation in another clinical study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Years
Maximum Age:
5 Months
Study:
NCT00224432
Study Brief:
Protocol Section:
NCT00224432