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

Biopolis S.L.3 sites in 1 country70 target enrollmentMay 23, 2018

ConditionsAtopic Dermatitis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Atopic Dermatitis
Sponsor: Biopolis S.L.
Enrollment: 70
Locations: 3
Primary Endpoint: Change from baseline in the SCORAD index at 12 weeks.
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 23, 2018

End Date

September 2019

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Biopolis S.L.

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

Change from baseline in the SCORAD index at 12 weeks.

Time Frame: 12-week

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 Outcomes

Use of antihistamines and other treatments.(12-week)
Disease-free time up to 24 weeks.(24-week)
Number of days that each patient requires the administration of topical corticosteroids in disease flares.(12-week)
Adherence to the treatment.(12-week)
Total dose of topical corticosteroids.(12-week)
Number of days that each patient requires the administration of topical corticosteroids.(12-week)
Number of patients who reach a CGI score lower than 2.(12-week)
Number of adverse events.(12-week)