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

Primary Purpose

Dermatitis, Atopic

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Probiotic
Placebo
Sponsored by
Biopolis S.L.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatitis, Atopic

Eligibility Criteria

4 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Centro Dermatologico Estetico de Alicante

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Probiotic

Placebo

Arm Description

daily intake of 1 capsule containing probiotic.

daily intake of 1 capsule containing placebo

Outcomes

Primary Outcome Measures

Time of use of topic corticosteroids
Duration of treatment with topic corticosteroids
Variation in SCORAD score during treatment

Secondary Outcome Measures

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

Full Information

First Posted
October 13, 2015
Last Updated
September 11, 2016
Sponsor
Biopolis S.L.
Collaborators
Korott, S.L.
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1. Study Identification

Unique Protocol Identification Number
NCT02585986
Brief Title
Intervention Study to Evaluate a Probiotic in Mild Atopic Dermatitis Young Patients
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biopolis S.L.
Collaborators
Korott, S.L.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Atopic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probiotic
Arm Type
Active Comparator
Arm Description
daily intake of 1 capsule containing probiotic.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
daily intake of 1 capsule containing placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Other Intervention Name(s)
Active formulation
Intervention Description
daily intake of 1 capsule probiotic
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
daily intake of 1 capsule containing placebo
Primary Outcome Measure Information:
Title
Time of use of topic corticosteroids
Description
Duration of treatment with topic corticosteroids
Time Frame
twelve weeks
Title
Variation in SCORAD score during treatment
Time Frame
twelve weeks
Secondary Outcome Measure Information:
Title
Variation in the Global Clinical Impression (CGI) score during treatment
Time Frame
twelve weeks
Title
Exposure to other treatments
Description
Duration of treatment with systemic corticosteroids or antihistamine drugs
Time Frame
twelve weeks
Title
side effects due to treatment in two arms of treatment
Description
Number of side effects due to probiotic and due to placebo
Time Frame
twelve weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vicente Navarro-López, MD
Organizational Affiliation
Universidad Católica San Antonio de Murcia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ana A. Ramirez-Boscá, MD
Organizational Affiliation
Universidad Católica San Antonio de Murcia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Dermatologico Estetico de Alicante
City
Alicante
ZIP/Postal Code
03014
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Intervention Study to Evaluate a Probiotic in Mild Atopic Dermatitis Young Patients

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