Probiotics in Adults: do They Improve Atopic Dermatitis?
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|ClinicalTrials.gov Identifier: NCT01500941|
Recruitment Status : Completed
First Posted : December 29, 2011
Last Update Posted : January 5, 2012
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:
- 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
- the normal intestinal flora (including probiotics) would play an important role in inducing immunological tolerance
- the hygiene hypothesis that the reduced bacterial environment would favour a type 2 response T and the development of allergic diseases
|Condition or disease||Intervention/treatment||Phase|
|Adult Atopic Dermatitis||Dietary Supplement: probiotics Other: maltodextrin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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 Start Date :||April 2010|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||September 2010|
|Active Comparator: probiotics||
Dietary Supplement: 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
|Placebo Comparator: maltodextrin||
- clinical effects of probiotics on adult atopic dermatitis [ Time Frame: 20 weeks ]To evaluate the clinical course of adult patients affected by atopic dermatitis after the intake of two probiotics vs placebo
- effects of probiotics on immune system and faecal microbiota in adult atopic dermatitis [ Time Frame: 20 weeks ]to evaluate these parameters: percentage of circulating Treg cells, percentage of Th17 cells, Th1 and Th2, percentage of Treg cells TLR2+, TLR4 + and TLR9 +, Quantization plasma LPS. Determination by gene amplification and culture of Lactobacillus salivarius and Bifidobacterium in the faeces of the two groups studied
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01500941
|Luigi Sacco Hospital|
|Milano, Italy, 20157|
|Study Director:||lorenzo drago, prof||Microbiology, Department of Clinical Sciences L. Sacco, University of Milan; 5Laboratory of Clinical Chemistry and Microbiology, IRCCS Galeazzi Orthopaedic Institute, Milan, Italy|