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Completed

NCT Number: NCT01500941

Probiotics in Adults: do They Improve Atopic Dermatitis?

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

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Key information

Conditions

Adult Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Luigi Sacco Hospital

Milan, 20157, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotics

Dietary Supplement

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

maltodextrin

Other

sachets

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

ASST Fatebenefratelli Sacco

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Dec 29, 2011
Registry last updated
Jan 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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