Topical L. Reuteri in Children With Atopic Dermatitis

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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Topical Lactobacillus Reuteri DSM 17938 to Evaluate Safety and Efficacy on Children With Mild or Moderate Atopic Dermatitis

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Other: Topical L. reeuteri


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children age 1 to 8 years old Atopic Dermatitis (AD) according to the criteria of Hanifin and Rajka SCORAD Index 15 to 50, inclusive Subjects whose parents or legal representative are willing to sign the informed consent When the child is 8, he/she must also give consent to participate in the study Exclusion Criteria: Use of phototherapy for atopic dermatitis Systemic or topic corticosteroids in tthe 30 days prior to the study Immunosuppressive or cytostatic drugs in the 2 months prior to the study Use of probiotics in the 2 weeks prior to the study Other allergic severe disease (asthma, allergic rhinitis) Systemic antibiotics in the four days prior to the study Fever (temperature> 37.5 °C axillary or equivalent) Pathologies associated with immunodeficiency or cancer processes Dermatological diseases that may hinder the evaluation of atopic dermatitis or require the continued use of topical corticosteroids Subjects for whom any of the studies products are contraindicated according to their technical specifications Subjects who have participated in research studies with any products in the 3 months prior to the trial

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, double blind, placebo controlled trial, 2 parallel arms. Children with mild or moderate atopic dermatitis will be randomly selected at the Pediatric Dermatologic Clinic-Hospital General GEA-Mexico if they fulfill selectioncriteria.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: L. reuteri<br>Topical administration of ointment with L. reuteri DSM17938, rubbed into skin twice per day | Other: Topical L. reeuteri<br>* Tubes with ointment containing L. reuteri DSM17938<br>|
| Placebo Comparator: Placebo<br>Rubbed into skin twice per day | Other: Topical L. reeuteri<br>* Tubes with ointment containing L. reuteri DSM17938<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin 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 | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of adverse events | To evaluate the frequency of adverse events after the use of topical L. reuteri DSM17938 | 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 | 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. | 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 | 16 weeks | 
| Changes on Skin microbiota | To evaluate the skin microbiome after the use of topical L. reuteri through genomic analysis. | 12 weeks |