This study evaluates the safety and efficacy of the probiotic L. reuteri vs control product as an adjuvant for improving the skin appearance of children with mild or moderate atopic dermatitis. All children will receive the standard of care. Half of the children will receive topical L. reuteri in emollient, while the other half will receive the standard of care plus control product
AD if a very frequent allergic skin disorders in children. Produce a negative significant impact on quality of life and related costs. Recently the changes of skin microbiota had been related with inadequate evolution of atopic dermatitis. L. reuteri had been identified with some effect to reduce skin inflammation and help to modulate inflammatory pathways on skin. Investigators expect using topical L. reuteri as adjuvant some improvement on skin appearance due to the mode of action previous referenced additionally to some potential changes on microbiome
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
102
Tubes with ointment containing L. reuteri DSM17938
Hospital General Dr. Manuel Gea Gonzalez
Mexico City, Mexico
RECRUITINGSkin appearance modification
To evaluate the use of a topical emolient containing L. reuteri DSM17938, in terms of its effect on appearance and symptomology in children with mild to moderate atopic dermatitis evaluated by SCORAD test
Time frame: 16 weeks
Frequency of adverse events
To evaluate the frequency of adverse events after the use of topical L. reuteri DSM17938
Time frame: 16 weeks
Changes on Quality of life
To evaluate the changes in quality of life after the use of topical L. reuteri DSM17938, evaluated by Children's Dermatology Life Quality Index Score
Time frame: 16 weeks
Changes on Family Quality of life: Familys Dermatology Life Quality Index Score
To evaluate the changes in quality of life after the use of topical L. reuteri DSM17938, evaluated by Familys Dermatology Life Quality Index Score.
Time frame: 16 weeks
Frecuency of rescue medications
To evaluate the improvement on AD control after the use of topical L. reuteri DSM17938 by frequency of rescue medications
Time frame: 16 weeks
Changes on Skin microbiota
To evaluate the skin microbiome after the use of topical L. reuteri through genomic analysis.
Time frame: 12 weeks
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