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

September 11, 2016 updated by: Biopolis S.L.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alicante, Spain, 03014
        • Centro Dermatológico Estético de Alicante

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 17 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Probiotic
daily intake of 1 capsule containing probiotic.
Dietary supplement: Probiotic
daily intake of 1 capsule probiotic
Other Names:
  • Active formulation
Placebo Comparator: Placebo
daily intake of 1 capsule containing placebo
Dietary supplement: Placebo
daily intake of 1 capsule containing placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variation in the Global Clinical Impression (CGI) score during treatment
Time Frame: twelve weeks
twelve weeks
Exposure to other treatments
Time Frame: twelve weeks
Duration of treatment with systemic corticosteroids or antihistamine drugs
twelve weeks
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
twelve weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biopolis S.L.

Collaborators

Korott, S.L.

Investigators

  • Principal Investigator: Ana A. Ramirez-Boscá, MD, Universidad Católica San Antonio de Murcia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

October 13, 2015

First Submitted That Met QC Criteria

October 22, 2015

First Posted (Estimate)

October 26, 2015

Study Record Updates

Last Update Posted (Estimate)

September 13, 2016

Last Update Submitted That Met QC Criteria

September 11, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATO/PRO1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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