NCT01500941

Probiotics in Adults: do They Improve Atopic Dermatitis?

Evaluation of the Effects of a Combination of Probiotics in the Treatment of Adult Atopic Dermatitis: Randomized Phase III, Double-blind Placebo-controlled

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: ASST Fatebenefratelli Sacco · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Conditions

• Adult Atopic Dermatitis

Interventions

Type	Name	Description
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
OTHER	maltodextrin	sachets

Timeline

• Start date: 2010-04-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2011-12-29
• Last updated: 2012-01-05

Locations

1 site across 1 country: Italy