Status:
COMPLETED
A Probiotic That Reduces Atopic Skin
Lead Sponsor:
Wecare Probiotics Co., Ltd.
Collaborating Sponsors:
Methodex
Conditions:
Atopic Skin
Children
Eligibility:
All Genders
2-14 years
Phase:
NA
Brief Summary
To assess the efficacy and safety of the use of probiotics as food supplements in reducing the SCORAD index in children with atopic skin compared with placebo. This is a randomized, placebo-controlled...
Eligibility Criteria
Inclusion
- Patients with atopic dermatitis in the sprouts phase with a moderate SCORAD index (16-40).
- Patients aged 2-14 years.
Exclusion
- Patients intolerant to gluten, lactose or cow's milk protein.
- Patients who change the type of diet during the study to improve their atopic dermatitis.
- Patients with atopic dermatitis in remission phase (absence of sprouts and with SCORAD index = 0).
- Patients with an allergy or intolerance to any of the ingredients in the formulation of the product under study.
- Patients taking immunomodulators, topical or oral antibiotics, topical or oral antihistamines, oral corticosteroids or antineoplastics.
- Subjects whose condition does not make them eligible for the study, according to the investigator.
Key Trial Info
Start Date :
January 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 21 2023
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT05989295
Start Date
January 26 2022
End Date
April 21 2023
Last Update
August 14 2023
Active Locations (2)
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1
CAP Alhambra of Hospitalet de Llobregat
Barcelona, Spain
2
CAP La Mina Carrer Mar Sant Adrià de Besos
Barcelona, Spain