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

NCT03822624 | Unknown

• 1 other identifier: ATOP/PRO-2
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 3

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

Keywords

Probiotic

Outcome Measures

Primary Outcomes (1)

• 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)

  12-week

Secondary Outcomes (8)

• Number of days that each patient requires the administration of topical corticosteroids.

  12-week

• Number of days that each patient requires the administration of topical corticosteroids in disease flares.

  12-week

• Total dose of topical corticosteroids.

  12-week

• Number of patients who reach a CGI score lower than 2.

  12-week

• Number of adverse events.

  12-week

Study Arms (2)

Probiotic group

EXPERIMENTAL

Dietary Supplement: Probiotic

Placebo group

PLACEBO COMPARATOR

Other: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

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

Probiotic group

Placebo OTHER

Placebo comparator with maltodextrin as a carrier.

Placebo group

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Biopolis S.L.: lead
• Korott, S.L.: collaborator

Study Sites (3)

Hospital Quirónsalud San José

Madrid, 28002, Spain

RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

RECRUITING

Hospital Vithas Nisa 9 de Octubre

Valencia, 46015, Spain

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

María Empar Chenoll, PhD

CONTACT

625851114; maria.chenoll@adm.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2018
• First Posted: January 30, 2019
• Study Start: May 23, 2018
• Primary Completion: May 1, 2019
• Study Completion: September 1, 2019
• Last Updated: February 5, 2019

Record last verified: 2019-02

Locations

ES (3)