Probiotics in Adults: do They Improve Atopic Dermatitis?

Last updated: January 3, 2012
Sponsor: ASST Fatebenefratelli Sacco
Overall Status: Completed

Phase

3

Condition

Dermatitis, Atopic

Rash

Atopic Dermatitis

Treatment

N/A

Clinical Study ID

NCT01500941
131/2010/77/2009/AP
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:Adults aged 18-55 years between

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

Exclusion

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, chronicgastrointestinal 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 toenrollment

  • Topical treatments with immunomodulators (tacrolimus or pimecrolimus) in the threemonths prior to enrollment

  • Acute or chronic infectious diseases

  • Pre-existing hypersensitivity to components contained in the probiotic

Study Design

Total Participants: 48
Study Start date:
April 01, 2010
Estimated Completion Date:
September 30, 2010

Connect with a study center

  • Luigi Sacco Hospital

    Milano, 20157
    Italy

    Site Not Available

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