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

Primary Purpose

Atopic Dermatitis

Status
Unknown status
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 Atopic Dermatitis focused on measuring Probiotic

Eligibility Criteria

4 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Hospital Quirónsalud San JoséRecruiting
  • Hospital Universitario Ramón y CajalRecruiting
  • Hospital Vithas Nisa 9 de OctubreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotic group

Placebo group

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
December 4, 2018
Last Updated
February 4, 2019
Sponsor
Biopolis S.L.
Collaborators
Korott, S.L.
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1. Study Identification

Unique Protocol Identification Number
NCT03822624
Brief Title
Study to Evaluate the Use of a Probiotic in SCORAD Reduction in Young Patients With Atopic Dermatitis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 23, 2018 (Actual)
Primary Completion Date
May 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Double-blind
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Probiotic group
Arm Type
Experimental
Arm Title
Placebo group
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Intervention Description
Probiotic mixture with three bacterial strains with maltodextrin as a carrier.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo comparator with maltodextrin as a carrier.
Primary Outcome Measure Information:
Title
Change from baseline in the SCORAD index at 12 weeks.
Description
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)
Time Frame
12-week
Secondary Outcome Measure Information:
Title
Number of days that each patient requires the administration of topical corticosteroids.
Time Frame
12-week
Title
Number of days that each patient requires the administration of topical corticosteroids in disease flares.
Time Frame
12-week
Title
Total dose of topical corticosteroids.
Time Frame
12-week
Title
Number of patients who reach a CGI score lower than 2.
Description
CGI: Clinical Global Impression Total: 0 - 5 (Higher values represent a worse outcome)
Time Frame
12-week
Title
Number of adverse events.
Time Frame
12-week
Title
Use of antihistamines and other treatments.
Time Frame
12-week
Title
Adherence to the treatment.
Description
Percentage of treatment intake days.
Time Frame
12-week
Title
Disease-free time up to 24 weeks.
Time Frame
24-week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
María Empar Chenoll, PhD
Phone
625851114
Email
maria.chenoll@adm.com
Facility Information:
Facility Name
Hospital Quirónsalud San José
City
Madrid
ZIP/Postal Code
28002
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Vithas Nisa 9 de Octubre
City
Valencia
ZIP/Postal Code
46015
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

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

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