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Completed

NCT Number: NCT02585986

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

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.

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Key information

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Dermatologico Estetico de Alicante

Alicante, 03014, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Probiotic

Dietary Supplement

daily intake of 1 capsule probiotic

Other names: Active formulation

Placebo

Dietary Supplement

daily intake of 1 capsule containing placebo

Primary outcomes

  1. Time of use of topic corticosteroids

    Time frame: twelve weeks

    Duration of treatment with topic corticosteroids

  2. Variation in SCORAD score during treatment

    Time frame: twelve weeks

Secondary outcomes

  1. Variation in the Global Clinical Impression (CGI) score during treatment

    Time frame: twelve weeks

  2. Exposure to other treatments

    Time frame: twelve weeks

    Duration of treatment with systemic corticosteroids or antihistamine drugs

  3. side effects due to treatment in two arms of treatment

    Time frame: twelve weeks

    Number of side effects due to probiotic and due to placebo

Sponsors and collaborators

Lead sponsor

Biopolis S.L.

Industry

Collaborators

  • Korott, S.L.

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Oct 26, 2015
Registry last updated
Sep 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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