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

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

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.

Study Overview

• Status: Unknown
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Dietary supplement: Probiotic; Other: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: María Empar Chenoll, PhD; Phone Number: 625851114; Email: maria.chenoll@adm.com

Study Locations

• Spain
  • Madrid, Spain, 28034
    • Recruiting
    • Hospital Universitario Ramón y Cajal
  • Madrid, Spain, 28002
    • Recruiting
    • Hospital Quironsalud San José
  • Valencia, Spain, 46015
    • Recruiting
    • Hospital Vithas Nisa 9 de Octubre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Probiotic group	Dietary supplement: Probiotic; Probiotic mixture with three bacterial strains with maltodextrin as a carrier.
PLACEBO_COMPARATOR: Placebo group	Other: Placebo; Placebo comparator with maltodextrin as a carrier.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	CGI: Clinical Global Impression Total: 0 - 5 (Higher values represent a worse outcome)	12-week
Number of adverse events.		12-week
Use of antihistamines and other treatments.		12-week
Adherence to the treatment.	Percentage of treatment intake days.	12-week
Disease-free time up to 24 weeks.		24-week

Collaborators and Investigators

• Sponsor: Biopolis S.L.
• Collaborators: Korott, S.L.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 23, 2018
• Primary Completion (ANTICIPATED): May 1, 2019
• Study Completion (ANTICIPATED): September 1, 2019

Study Registration Dates

• First Submitted: December 4, 2018
• First Submitted That Met QC Criteria: January 28, 2019
• First Posted (ACTUAL): January 30, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 5, 2019
• Last Update Submitted That Met QC Criteria: February 4, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Probiotic
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: ATOP/PRO-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No