Probiotics in Adults: do They Improve Atopic Dermatitis?

Phase 3

Completed

• Conditions: Adult Atopic Dermatitis
• Interventions: Dietary Supplement: probiotics; Other: maltodextrin

• Registration Number: NCT01500941
• Lead Sponsor: ASST Fatebenefratelli Sacco

Brief Summary

Probiotics are suggested to have beneficial effects in atopic dermatitis (AD) treatment and prevention but their precise role is not yet clear.

The aim of this randomized double blinded active treatment vs placebo study was to evaluate clinical efficacy of intake of a combination of two probiotics (Lactobacillus salivarius LS01 and Bifidobacterium breve BR03) for the treatment of adult AD patients.

The rationale for the use of probiotics in the treatment of atopic dermatitis would be due to some experimental hypotheses:

1. The use of these microbial agents at an early age seems to play an important role in inducing immunity T type 1 (Th1) and inhibit the development of a Th2 response IgE mediated

2. the normal intestinal flora (including probiotics) would play an important role in inducing immunological tolerance

3. the hygiene hypothesis that the reduced bacterial environment would favour a type 2 response T and the development of allergic diseases

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Study First Submitted: 2011-12-21
• Study First Submitted QC: 2011-12-28
• Study First Posted: 2011-12-29
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-03
• Last Update Posted: 2012-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Adults aged 18-55 years between

• Diagnosis of DA moderate and / or severe, as assessed by the use of a standardized index of severity of AD (SCORAD = Scoring Atopic Dermatitis index) (42), prepared by the European Task Force for atopic dermatitis

Exclusion Criteria

Allergic contact dermatitis (ACD), active

• In the absence of known food allergy elimination diet
• Chronic diseases (autoimmune diseases, COPD, heart disease, IRC, CNS disease, chronic gastrointestinal diseases, diabetes, congenital or acquired immunosuppression)
• Pregnancy and / or lactation
• Treatment with probiotics in the 6 months preceding enrollment
• Treatment with steroids and antihistamines systemically in the three months prior to enrollment
• Topical treatments with immunomodulators (tacrolimus or pimecrolimus) in the three months prior to enrollment
• Acute or chronic infectious diseases
• Pre-existing hypersensitivity to components contained in the probiotic

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
probiotics	probiotics	-
maltodextrin	maltodextrin	-

Primary Outcome Measures

Name	Time	Method
clinical effects of probiotics on adult atopic dermatitis	20 weeks	To evaluate the clinical course of adult patients affected by atopic dermatitis after the intake of two probiotics vs placebo

Secondary Outcome Measures

Name	Time	Method
effects of probiotics on immune system and faecal microbiota in adult atopic dermatitis	20 weeks	to evaluate these parameters: percentage of circulating Treg cells, percentage of Th17 cells, Th1 and Th2, percentage of Treg cells TLR2+, TLR4 + and TLR9 +, Quantization plasma LPS. Determination by gene amplification and culture of Lactobacillus salivarius and Bifidobacterium in the faeces of the two groups studied

Trial Locations

Locations (1)

Luigi Sacco Hospital; 🇮🇹 Milano, Italy