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

Biopolis

Status

Completed

Conditions

Dermatitis, Atopic

Treatments

Dietary Supplement: Placebo

Dietary Supplement: Probiotic

Study type

Interventional

Funder types

Industry

Identifiers

NCT02585986

ATO/PRO1

Details and patient eligibility

About

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.

Full 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.

Enrollment

51 patients

Sex

All

Ages

4 to 17 years old

Volunteers

Accepts 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.