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

Biopolis

Status

Unknown

Conditions

Atopic Dermatitis

Treatments

Other: Placebo

Dietary Supplement: Probiotic

Study type

Interventional

Funder types

Industry

Identifiers

NCT03822624

ATOP/PRO-2

Details and patient eligibility

About

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.

Enrollment

70 estimated patients

Sex

All

Ages

4 to 17 years old

Volunteers

No 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).