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Probiotics in Adults: do They Improve Atopic Dermatitis?

Primary Purpose

Adult Atopic Dermatitis

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
probiotics
maltodextrin
Sponsored by
ASST Fatebenefratelli Sacco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult Atopic Dermatitis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Luigi Sacco Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

probiotics

maltodextrin

Arm Description

Outcomes

Primary Outcome Measures

clinical effects of probiotics on adult atopic dermatitis
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
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

Full Information

First Posted
December 21, 2011
Last Updated
January 3, 2012
Sponsor
ASST Fatebenefratelli Sacco
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1. Study Identification

Unique Protocol Identification Number
NCT01500941
Brief Title
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

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
ASST Fatebenefratelli Sacco

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
probiotics
Arm Type
Active Comparator
Arm Title
maltodextrin
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
probiotics
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
maltodextrin
Intervention Description
sachets
Primary Outcome Measure Information:
Title
clinical effects of probiotics on adult atopic dermatitis
Description
To evaluate the clinical course of adult patients affected by atopic dermatitis after the intake of two probiotics vs placebo
Time Frame
20 weeks
Secondary Outcome Measure Information:
Title
effects of probiotics on immune system and faecal microbiota in adult atopic dermatitis
Description
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
Time Frame
20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
lorenzo drago, prof
Organizational Affiliation
Microbiology, Department of Clinical Sciences L. Sacco, University of Milan; 5Laboratory of Clinical Chemistry and Microbiology, IRCCS Galeazzi Orthopaedic Institute, Milan, Italy
Official's Role
Study Director
Facility Information:
Facility Name
Luigi Sacco Hospital
City
Milano
ZIP/Postal Code
20157
Country
Italy

12. IPD Sharing Statement

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Probiotics in Adults: do They Improve Atopic Dermatitis?

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