Status:
COMPLETED
Probiotics in Adults: do They Improve Atopic Dermatitis?
Lead Sponsor:
ASST Fatebenefratelli Sacco
Conditions:
Adult Atopic Dermatitis
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
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 treatm...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01500941
Start Date
April 1 2010
End Date
September 1 2010
Last Update
January 5 2012
Active Locations (1)
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1
Luigi Sacco Hospital
Milan, Italy, 20157