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:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT03863418
Eligibility Criteria:
Inclusion Criteria:
* Children aged 6-36 months
* diagnosis of Atopic Dermatitis according to SCORAD index
Exclusion Criteria
* Age \< 6 months
* age \> 36 months,
* skin infections,
* ichthyosis,
* food allergies,
* other allergic diseases,
* chronic systemic diseases,
* congenital cardiac defects,
* active tuberculosis,
* autoimmune diseases,
* immunodeficiency,
* chronic inflammatory bowel diseases,
* celiac disease,
* cystic fibrosis,
* metabolic diseases,
* malignancy,
* chronic pulmonary diseases,
* malformations of the gastrointestinal and/or respiratory tract,
* administration of prebiotics/ probiotics/symbiotic/systemic immunomodulators during the 4 weeks before enrolment,
* treatments with topical immunomodulators (Tacrolimus or Pimecrolimus) over the three months prior to enrolment;
* use of corticosteroids or calcineurin antagonists or phototherapy in the previous 4 weeks,
* use of systemic antibiotics or anti-mycotic drugs during 4 weeks before 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;
* hypersensitivity to components contained in study product.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
36 Months
Study:
NCT03863418
Study Brief:
Protocol Section:
NCT03863418