NCT01500941

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:

  1. 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. 2.the normal intestinal flora (including probiotics) would play an important role in inducing immunological tolerance
  3. 3.the hygiene hypothesis that the reduced bacterial environment would favour a type 2 response T and the development of allergic diseases

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2010

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 29, 2011

Completed
Last Updated

January 5, 2012

Status Verified

January 1, 2012

Enrollment Period

5 months

First QC Date

December 21, 2011

Last Update Submit

January 3, 2012

Conditions

Adult Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

  • 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

    20 weeks

Secondary Outcomes (1)

  • effects of probiotics on immune system and faecal microbiota in adult atopic dermatitis

    20 weeks

Study Arms (2)

probiotics

ACTIVE COMPARATOR
Dietary Supplement: probiotics

maltodextrin

PLACEBO COMPARATOR
Other: maltodextrin

Interventions

probioticsDIETARY_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

probiotics
maltodextrinOTHER

sachets

maltodextrin

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Luigi Sacco Hospital

Milan, 20157, Italy

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Probioticsmaltodextrin

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
head allergy and clinical immunology departement

Study Record Dates

First Submitted

December 21, 2011

First Posted

December 29, 2011

Study Start

April 1, 2010

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

January 5, 2012

Record last verified: 2012-01

Locations

IT(1)