Study to Evaluate the Use of a Probiotic in SCORAD Reduction in Young Patients With Atopic Dermatitis

Study Overview
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Brief Summary
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The study's objective is to confirm that an oral probiotic treatment reduces the signs and symptoms of moderate atopic dermatitis determined by SCORAD, in patients aged 4 to 17 years, as compared to placebo. It will also be examined if the probiotic treatment, as compared to placebo, reduces the quantity of topical steroids used to treat disease flares, and increases the time till the first disease flare after the end of treatment.

Official Title
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Randomized, Double Blind, Placebo Controlled Study to Evaluate Efficiency and Safety on the Use of a Probiotic in SCORAD Reduction in 4-to-17 Years-old Patients With Atopic Dermatitis

Conditions
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Atopic Dermatitis

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 4 to 17 years, both inclusive. Diagnosed with atopic dermatitis according to Hanifin and Rajka criteria. SCORAD index of 20-40, both inclusive. Patients whose parents or legal guardian sign the informed consent. The minor over 12 years must also give their consent to participate in the trial. Exclusion Criteria: Pregnancy. Breast feeding. Women of childbearing age who, in the opinion of the investigator, do not commit to using an effective method of contraception, if they have an active sex life or start during the trial. Treated with phototherapy for the atopic dermatitis in the previous 2 months. Treated with systemic corticosteroids in the previous 2 months or need for corticosteroids anticipated during the first 12 weeks of the study. Having undergone cytotoxic or immunosuppressive therapy in the previous 2 months or having an anticipated need for cytotoxic or immunosuppressive therapy during the first 12 weeks of the study. Treated with probiotics in the previous two months. Treated with systemic antibiotics in the previous four days. Patients with a fever (temperature > 37.5°C, axillary or equivalent). Serious allergic diseases. Diseases related to immunodeficiency processes or cancer. Other skin diseases that can make assessment of the atopic dermatitis difficult or which require the continuous use of topical corticosteroids. Patients in whom any of the study products is contraindicated according to its summary of product characteristics. Patients who have participated in research studies with medicinal products during the previous 3 months. Patients with gluten or lactose intolerance or inflammatory bowel disease (Crohn's disease or ulcerative colitis).

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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No

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 |
| --- | --- |
| Experimental: Probiotic group<br> | Dietary Supplement: Probiotic<br>* Probiotic mixture with three bacterial strains with maltodextrin as a carrier.<br>|
| Placebo Comparator: Placebo group<br> | Other: Placebo<br>* Placebo comparator with maltodextrin as a carrier.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the SCORAD index at 12 weeks. | SCORAD: SCOring of Atopic Dermatitis Subscales: Eczema Spread (A): 0 - 20 Eczema Intensity (B): 0 - 63 Subjective Symptoms (C): 0 - 20 Total = (A/5) + (Bx7/2) + C Total: 0 - 103 (Higher values represent a worse outcome) | 12-week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days that each patient requires the administration of topical corticosteroids. |  | 12-week | 
| Number of days that each patient requires the administration of topical corticosteroids in disease flares. |  | 12-week | 
| Total dose of topical corticosteroids. |  | 12-week | 
| Number of patients who reach a CGI score lower than 2. | CGI: Clinical Global Impression Total: 0 - 5 (Higher values represent a worse outcome) | 12-week | 
| Number of adverse events. |  | 12-week | 
| Use of antihistamines and other treatments. |  | 12-week | 
| Adherence to the treatment. | Percentage of treatment intake days. | 12-week | 
| Disease-free time up to 24 weeks. |  | 24-week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotic