Methods |
Randomised double‐blind placebo‐controlled clinical trial |
Participants |
Children of both genders between 4 and 17 years of age. Estimated enrolment: 50. Country: Spain Inclusion criteria:
4 to 17 years of age
Diagnosis of atopic dermatitis according to Hanifin and Rajka diagnostic criteria for atopic dermatitis
SCORAD score ranging from 20 to 40
Using topical corticosteroids to treat atopic dermatitis flare‐ups
Parent or legal representative has signed informed consent. If the patient is 12 years old or older, the patient must sign a consent to enter the trial
Exclusion criteria
Pregnancy
Breastfeeding
Women of childbearing age who do not make a commitment to use any effective contraceptive method
Phototherapy treatments for atopic dermatitis
Systemic corticoid therapy in the last 2 months
Immunosuppressive or cytostatic treatment in the last 2 months
Probiotic treatment in the last 2 months
Systemic antibiotic in the last 4 months
Fever (axillary temperature > 37°C or equivalent)
Severe allergic disease
Immunodeficiency or cancer‐related processes
Other dermatological pathologies that could make the atopic dermatitis evaluation difficult, or that require continued use of topical corticosteroids
Any contraindication to any product or drug used during the trial, according to technical files
Participation in any drug clinical trial in the last 3 months
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Interventions |
Dietary supplement: probiotic ‐ daily intake of 1 capsule. Freeze‐dried powder: 10⁹ CFUs of Bifidobacterium lactis CECT 8145, Bifidobacterium longum CECT 7347, and Lactobacillus casei CECT 9104 and maltodextrin
Dietary supplement: placebo ‐ daily intake of 1 capsule containing maltodextrin
Duration of intervention: 12 weeks |
Outcomes |
Primary outcome measures
Secondary outcome measures
Variation in the Global Clinical Impression (CGI) score during treatment (time frame: 12 weeks)
Exposure to other treatments (time frame: 12 weeks)
Duration of treatment with systemic corticosteroids or antihistamine drugs
Side effects due to treatment in 2 treatment arms (time frame: 12 weeks)
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Notes |
Current status: results published Registration: NCT02585986 (ClinicalTrials.gov). Sponsor: Biopolis SL |