Intervention Study to Evaluate a Probiotic in Mild Atopic Dermatitis Young Patients

Study Overview
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Brief Summary
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The aim of the study is to evaluate the beneficial effect of a probiotic preparation with an antiinflammatory and modulating activity on immunological processes, with positive results on different inflammatory and atopic conditions.

Detailed Description
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In this study the investigators evaluate the safety and efficacy of a probiotic formulation in the reduction of symptoms and use of topic and systemic corticosteroids and antihistamines in the treatment of mild atopic dermatitis according to Hanifin and Rajka diagnostic criteria for atopic dermatitis, with a SCORAD (Scoring Atopic Dermatitis) index of 20 to 40, in patients 4 to 18 years old, that require the use of said drugs due to disease flare-ups, and to whom the usage of topic corticoids to control said flare-ups is indicated.

Official Title
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Randomized, Double Blind, Placebo-controlled Intervention Study to Evaluate Safety and Efficiency of a Probiotic in Symptoms Reduction and Use of Topic Corticoids in Mild Atopic Dermatitis Patients Aged 4 to 17 Years

Conditions
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Dermatitis, Atopic

Intervention / Treatment
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* Dietary Supplement: Probiotic
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients that are 4 to 17 years of age. Patients diagnosed of atopic dermatitis according to Hanifin and Rajka diagnostic criteria for atopic dermatitis. Patients with a SCORAD score ranging from 20 to 40. Patients that are actually using, or in which the use of topic corticosteroids to treat the atopic dermatitis flare-ups. Patients whose parents or legal representative have signed the informed consent. If the patient is 12 year old or older, the patient has to sign a consent to enter the trial. Exclusion Criteria: Pregnancy. Breastfeeding. Women of childbearing age that do not make a commitment to use any effective contraceptive method. Phototherapy treatments to atopic dermatitis Systemic corticoid therapy in the last two months. Immunosuppressive or cytostatic treatment in the last two months. Probiotic treatment in the last two months. Systemic antibiotic in the last four months. Fever (axillary temperature > 37ºC or equivalent) Severe allergic diseases- Immunodeficiency or cancer related processes. Other dermatological pathologies that could difficult the atopic dermatitis evaluation, or that require the continued use of topic corticosteroids. Any contraindication to any product or drug used during the trial, according to their technical files. Participation in any drug clinical trial in the last 3 months.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 17 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Probiotic<br>daily intake of 1 capsule containing probiotic. | Dietary Supplement: Probiotic<br>* daily intake of 1 capsule probiotic<br>* Other names: Active formulation;|
| Placebo Comparator: Placebo<br>daily intake of 1 capsule containing placebo | Dietary Supplement: Placebo<br>* daily intake of 1 capsule containing placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of use of topic corticosteroids | Duration of treatment with topic corticosteroids | twelve weeks | 
| Variation in SCORAD score during treatment |  | twelve weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation in the Global Clinical Impression (CGI) score during treatment |  | twelve weeks | 
| Exposure to other treatments | Duration of treatment with systemic corticosteroids or antihistamine drugs | twelve weeks | 
| side effects due to treatment in two arms of treatment | Number of side effects due to probiotic and due to placebo | twelve weeks |