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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03822624
• Other study ID #: ATOP/PRO-2
• Status: Recruiting
• Phase: N/A
• Start date: May 23, 2018
• Est. completion date: September 2019

Study information

• Verified date: February 2019
• Source: Biopolis S.L.
• Contact: María Empar Chenoll, PhD
• Phone: 625851114
• Email: maria.chenoll[@]adm.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: September 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

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).

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Dietary Supplement:
• Probiotic
Probiotic mixture with three bacterial strains with maltodextrin as a carrier.

Other:
• Placebo
Placebo comparator with maltodextrin as a carrier.

Locations

Country	Name	City	State
Spain	Hospital Quirónsalud San José	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Vithas Nisa 9 de Octubre	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
Biopolis S.L.	Korott, S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of days that each patient requires the administration of topical corticosteroids.		12-week
Secondary	Number of days that each patient requires the administration of topical corticosteroids in disease flares.		12-week
Secondary	Total dose of topical corticosteroids.		12-week
Secondary	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
Secondary	Number of adverse events.		12-week
Secondary	Use of antihistamines and other treatments.		12-week
Secondary	Adherence to the treatment.	Percentage of treatment intake days.	12-week
Secondary	Disease-free time up to 24 weeks.		24-week