A Probiotic That Reduces Atopic Skin

Study Overview
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Brief Summary
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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, double-blind clinical trial with 2 parallel groups, which will include 32 patients who attend some of the research centers. Patients will be randomized into one of the 2 study groups (allocation ratio 1: 1): Experimental group (Lactobacillus rhamnosus LRa05) and placebo group (placebo). The reduction of the SCORAD index, the number of sprouts in 12 weeks, the days of use of topical corticosteroids and one valuations of the skin condition (hydration).

Official Title
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The Efficacy, Safety and Acceptability of a Probiotic in Reducing the Scorad Index in Children With Atopic Skin

Conditions
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Atopic Skin, Children

Intervention / Treatment
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* Dietary Supplement: probiotic LRa05


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with atopic dermatitis in the sprouts phase with a moderate SCORAD index (16-40). Patients aged 2-14 years. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo group<br>2.0 g maltodextrin /sachet； Take one sachet a day before meals. Dilute in water； Store in a cool, dry place without sun exposure. | Dietary Supplement: probiotic LRa05<br>* treatment about 12 weeks<br>|
| Active Comparator: Probiotic group<br>(2B CFU/sachet) Lactobacillus rhamnosus LRa05 and maltodextrin Take one sachet a day before meals. Dilute in water； Store in a cool, dry place without sun exposure. | Dietary Supplement: probiotic LRa05<br>* treatment about 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the outbreaks of atopic skin | use the SCORAD index to measure the outbreaks of atopic skin | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atopic skin;, eczema;, child population;, probiotic