Clinical trial NCT01500941: Probiotics in Adults: do They Improve Atopic Dermatitis?
Official title: Evaluation of the Effects of a Combination of Probiotics in the Treatment of Adult Atopic Dermatitis: Randomized Phase III, Double-blind Placebo-controlled
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Adult Atopic Dermatitis
Lead sponsor: ASST Fatebenefratelli Sacco
Sponsor class: OTHER
First posted: 2011-12-29
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: clinical effects of probiotics on adult atopic dermatitis
timeFrame: 20 weeks
Secondary outcomes:
measure: effects of probiotics on immune system and faecal microbiota in adult atopic dermatitis
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Luigi Sacco Hospital
Study officials:
affiliation: Microbiology, Department of Clinical Sciences L. Sacco, University of Milan; 5Laboratory of Clinical Chemistry and Microbiology, IRCCS Galeazzi Orthopaedic Institute, Milan, Italy
name: lorenzo drago, prof
role: STUDY_DIRECTOR
References: