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. 2018 Nov 21;2018(11):CD006135. doi: 10.1002/14651858.CD006135.pub3

NCT02585986.

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

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
  • Time of use of topical corticosteroids (time frame: 12 weeks)

  • Variation in SCORAD score during treatment (time frame: 12 weeks)


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)

Notes Current status: results published
Registration: NCT02585986 (ClinicalTrials.gov).
Sponsor: Biopolis SL