Probiotics in Adults: do They Improve Atopic Dermatitis?

NCT ID: NCT01500941

Last Updated: 2012-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2010-09-30

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

Conditions

Adult Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

probiotics

Group Type: ACTIVE_COMPARATOR

probiotics

Intervention Type: DIETARY_SUPPLEMENT

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

maltodextrin

Group Type: PLACEBO_COMPARATOR

maltodextrin

Intervention Type: OTHER

sachets

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

maltodextrin

sachets

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ASST Fatebenefratelli Sacco

OTHER

Sponsor Role: lead

Responsible Party

Iemoli Enrico

head allergy and clinical immunology departement

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

lorenzo drago, prof

Role: STUDY_DIRECTOR

Microbiology, Department of Clinical Sciences L. Sacco, University of Milan; 5Laboratory of Clinical Chemistry and Microbiology, IRCCS Galeazzi Orthopaedic Institute, Milan, Italy

Locations

Luigi Sacco Hospital

Milan, , Italy

Countries

Italy

Other Identifiers

131/2010/77/2009/AP

Identifier Type: -

Identifier Source: org_study_id