The study's objective is to confirm that an oral probiotic treatment reduces the signs and symptoms of moderate atopic dermatitis determined by SCORAD, in patients aged 4 to 17 years, as compared to placebo. It will also be examined if the probiotic treatment, as compared to placebo, reduces the quantity of topical steroids used to treat disease flares, and increases the time till the first disease flare after the end of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
70
Hospital Quirónsalud San José
Madrid, Spain
RECRUITINGHospital Universitario Ramón y Cajal
Madrid, Spain
RECRUITINGHospital Vithas Nisa 9 de Octubre
Valencia, Spain
RECRUITINGChange from baseline in the SCORAD index at 12 weeks.
SCORAD: SCOring of Atopic Dermatitis Subscales: Eczema Spread (A): 0 - 20 Eczema Intensity (B): 0 - 63 Subjective Symptoms (C): 0 - 20 Total = (A/5) + (Bx7/2) + C Total: 0 - 103 (Higher values represent a worse outcome)
Time frame: 12-week
Number of days that each patient requires the administration of topical corticosteroids.
Time frame: 12-week
Number of days that each patient requires the administration of topical corticosteroids in disease flares.
Time frame: 12-week
Total dose of topical corticosteroids.
Time frame: 12-week
Number of patients who reach a CGI score lower than 2.
CGI: Clinical Global Impression Total: 0 - 5 (Higher values represent a worse outcome)
Time frame: 12-week
Number of adverse events.
Time frame: 12-week
Use of antihistamines and other treatments.
Time frame: 12-week
Adherence to the treatment.
Percentage of treatment intake days.
Time frame: 12-week
Disease-free time up to 24 weeks.
Time frame: 24-week
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