Clinical trial: Probiotic Lactobacillus Rhamnosus GG for Pediatric Atopic Dermatitis (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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 6 Months old.
Subject must be at most 36 Months

Patient description (medical language): A 2-year-old boy is brought to the office by his parents due to a rash that started 1 week ago.  A similar red, itchy rash on the cheeks, trunk, and arms has occurred intermittently since infancy.  The patient has had a few upper respiratory infections but no major illnesses.  Vaccinations are up to date, and he takes no medications. He is on a balanced diet, and he is healthy in appearance.  Vital signs and milestone examination are within normal limits.  Similar findings are observed on the cheeks and proximal upper extremities.  The diaper area is clear, and no mucosal lesions are present.

Patient description (patient's own words): I just brought my two-year-old son to the doctor's office because he had a rash for like one week. His rash was on the cheeks, the trunk, and his arms. He already had this before, and it keeps coming back from time to time to time. In the past, he had some respiratory infections but he has never been this sick. His vaccinations are up to date, and he doesn't take any medication. He's healthy with a nice diet. The doctor told me his vitals and milestone examinations were normal. The doctor also said there was a rash around the cheek and the upper part of his arms. The diaper area is okay, and there are no lesions.

Does the patient match the trial criteria? Entailment