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

Not Applicable

Completed

• Conditions: Dermatitis, Atopic
• Interventions: Dietary Supplement: Probiotic; Dietary Supplement: Placebo

• Registration Number: NCT02585986
• Lead Sponsor: Biopolis S.L.

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-10-13
• Study First Submitted QC: 2015-10-22
• Study First Posted: 2015-10-26
• Study Start: 2016-01
• Primary Completion: 2016-07
• Study Completion: 2016-08
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-11
• Last Update Posted: 2016-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic	Probiotic	daily intake of 1 capsule containing probiotic.
Placebo	Placebo	daily intake of 1 capsule containing placebo

Primary Outcome Measures

Name	Time	Method
Time of use of topic corticosteroids	twelve weeks	Duration of treatment with topic corticosteroids
Variation in SCORAD score during treatment	twelve weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centro Dermatologico Estetico de Alicante; 🇪🇸 Alicante, Spain