NCT02585986

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

Randomized, Double Blind, Placebo-controlled Intervention Study to Evaluate Safety and Efficiency of a Probiotic in Symptoms Reduction and Use of Topic Corticoids in Mild Atopic Dermatitis Patients Aged 4 to 17 Years

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Biopolis S.L. · Industry
• Sex: All
• Age: 4 Years – 17 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Dermatitis, Atopic

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic	daily intake of 1 capsule probiotic
DIETARY_SUPPLEMENT	Placebo	daily intake of 1 capsule containing placebo

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-07-01
• Completion: 2016-08-01
• First posted: 2015-10-26
• Last updated: 2016-09-13

Locations

1 site across 1 country: Spain