Status:
UNKNOWN
Probiotic Lactobacillus Rhamnosus GG for Pediatric Atopic Dermatitis
Lead Sponsor:
Federico II University
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
6-36 years
Phase:
NA
Brief Summary
Atopic dermatitis (AD) is a multifactorial, chronic inflammatory skin disorder that results in areas of dry, itchy skin. AD affects up to 20% of children in Western societies and represents a prevalen...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03863418
Start Date
May 15 2019
End Date
December 31 2020
Last Update
March 6 2019
Active Locations (1)
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1
University of Naples Federico II
Naples, Italy, 80131