Probiotics in Adults: do They Improve Atopic Dermatitis?

ASST Fatebenefratelli Sacco

Status and phase: Completed; Phase 3

Conditions: Adult Atopic Dermatitis

Treatments: Other: maltodextrin; Dietary Supplement: probiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT01500941

131/2010/77/2009/AP

Details and patient eligibility

About

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

Enrollment: 48 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups, including a placebo group

probiotics

Active Comparator group

Treatment:

Dietary Supplement: probiotics

maltodextrin

Placebo Comparator group

Treatment:

Other: maltodextrin