Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Probiotics in Adults: do They Improve Atopic Dermatitis?

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Iemoli Enrico, Ospedale L. Sacco - Polo Universitario
ClinicalTrials.gov Identifier:
NCT01500941
First received: December 21, 2011
Last updated: January 3, 2012
Last verified: January 2012
  Purpose

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

Condition Intervention Phase
Adult Atopic Dermatitis
Dietary Supplement: probiotics
Other: maltodextrin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Further study details as provided by Ospedale L. Sacco – Polo Universitario:

Primary Outcome Measures:
  • clinical effects of probiotics on adult atopic dermatitis [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]
    To evaluate the clinical course of adult patients affected by atopic dermatitis after the intake of two probiotics vs placebo


Secondary Outcome Measures:
  • effects of probiotics on immune system and faecal microbiota in adult atopic dermatitis [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    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


Enrollment: 48
Study Start Date: April 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Other: maltodextrin
sachets

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01500941

Locations
Italy
Luigi Sacco Hospital
Milano, Italy, 20157
Sponsors and Collaborators
Ospedale L. Sacco – Polo Universitario
Investigators
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
  More Information

No publications provided

Responsible Party: Iemoli Enrico, head allergy and clinical immunology departement, Ospedale L. Sacco - Polo Universitario
ClinicalTrials.gov Identifier: NCT01500941     History of Changes
Other Study ID Numbers: 131/2010/77/2009/AP
Study First Received: December 21, 2011
Last Updated: January 3, 2012
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Genetic Diseases, Inborn
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic

ClinicalTrials.gov processed this record on November 20, 2014