Probiotics in Adults: do They Improve Atopic Dermatitis?

Evaluation of the Effects of a Combination of Probiotics in the Treatment of Adult Atopic Dermatitis: Randomized Phase III, Double-blind Placebo-controlled

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

Study Overview

• Status: Completed
• Conditions: Adult Atopic Dermatitis
• Intervention / Treatment: Dietary supplement: probiotics; Other: maltodextrin

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Milano, Italy, 20157
    • Luigi Sacco Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 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
Placebo Comparator: maltodextrin	Other: maltodextrin; sachets
Active Comparator: probiotics	Dietary supplement: probiotics; a mixture of Lactobacillus LS01 DSM 2275 and Bifidobacterium BR03 DSM 16604 at a dose of 1 x 109 colony forming units (CFU)/g each in maltodextrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical effects of probiotics on adult atopic dermatitis	To evaluate the clinical course of adult patients affected by atopic dermatitis after the intake of two probiotics vs placebo	20 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
effects of probiotics on immune system and faecal microbiota in adult atopic dermatitis	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	20 weeks

Collaborators and Investigators

• Sponsor: ASST Fatebenefratelli Sacco
• Investigators: Study Director: lorenzo drago, prof, Microbiology, Department of Clinical Sciences L. Sacco, University of Milan; 5Laboratory of Clinical Chemistry and Microbiology, IRCCS Galeazzi Orthopaedic Institute, Milan, Italy

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: December 21, 2011
• First Submitted That Met QC Criteria: December 28, 2011
• First Posted (Estimate): December 29, 2011

Study Record Updates

• Last Update Posted (Estimate): January 5, 2012
• Last Update Submitted That Met QC Criteria: January 3, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• 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: 131/2010/77/2009/AP