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

NCT ID: NCT03822624

Last Updated: 2019-02-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-23
• Study Completion Date: 2019-09-30

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Probiotic group

Group Type: EXPERIMENTAL

Probiotic

Intervention Type: DIETARY_SUPPLEMENT

Probiotic mixture with three bacterial strains with maltodextrin as a carrier.

Placebo group

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo comparator with maltodextrin as a carrier.

Interventions

Probiotic

Probiotic mixture with three bacterial strains with maltodextrin as a carrier.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo comparator with maltodextrin as a carrier.

Intervention Type: OTHER

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).

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korott, S.L.

INDUSTRY

Sponsor Role: collaborator

Biopolis S.L.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Quirónsalud San José

Madrid, , Spain

Site Status: RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, , Spain

Site Status: RECRUITING

Hospital Vithas Nisa 9 de Octubre

Valencia, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

María Empar Chenoll, PhD

Role: CONTACT

maria.chenoll@adm.com

625851114

Other Identifiers

ATOP/PRO-2

Identifier Type: -

Identifier Source: org_study_id