Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000615684
Ethics application status
Approved
Date submitted
23/09/2005
Date registered
7/10/2005
Date last updated
7/10/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Probiotics in the management of eczema
Scientific title
A Double-Blind, Randomised, Placebo controlled study to identify markers for the differential response of children with eczema following treatment with probiotics.
Secondary ID [1] 191 0
REC 1515/10/2006
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ATOPIC DERMATITIS 747 0
Condition category
Condition code
Skin 823 823 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Children aged 6 month to 12 years with eczema (Scorad of greater than 15) given lactobillus GG 3x10e8 to 1x10e9 cfu twice daily for 8 weeks observation.
Intervention code [1] 665 0
None
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 1055 0
SCORAD (SCORing Atopic Dermatitis Clinical Score)
Timepoint [1] 1055 0
Measured at week 0, week 8 and week 16.
Secondary outcome [1] 1963 0
Gut permeability using intestinal sugar permeability test.
Timepoint [1] 1963 0
All secondary outcomes are measured at: subject commencement; at 2 months (treatment completion) and at 4 months (subject completion).
Secondary outcome [2] 1964 0
IL2, TNFa, IFNg, IL4, IL5, IL10, TGFb.
Timepoint [2] 1964 0
All secondary outcomes are measured at: subject commencement; at 2 months (treatment completion) and at 4 months (subject completion).
Secondary outcome [3] 1965 0
CCR4/CLA expression on CD4 cells.
Timepoint [3] 1965 0
All secondary outcomes are measured at: subject commencement; at 2 months (treatment completion) and at 4 months (subject completion).

Eligibility
Key inclusion criteria
Eczema - SCORAD of 15 or greaterGuardian's proficient in EnglishNot previously actively treated with probiotics for eczema. No current chronic illness other than asthma, allergic, rhinitis or food allergy.
Minimum age
6 Months
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered packets of sealed probiotic/placebo capsules visually identical in all respects.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random allocation was generated using a computer software program (http://www.randomization.com). 1:1 randomisation was stratified in blocks.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/08/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 911 0
Charities/Societies/Foundations
Name [1] 911 0
Channel 7 Children's Research Foundation Grant
Country [1] 911 0
Australia
Primary sponsor type
Hospital
Name
The Women's & Children's Hospital (part of the Children, Youth and Women's Health Service)
Address
Country
Australia
Secondary sponsor category [1] 770 0
None
Name [1] 770 0
Nil
Address [1] 770 0
Country [1] 770 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2197 0
The Women's and Children's Hospital
Ethics committee address [1] 2197 0
72 King William Rd North Adelaide, SA 5006
Ethics committee country [1] 2197 0
Date submitted for ethics approval [1] 2197 0
Approval date [1] 2197 0
Ethics approval number [1] 2197 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36036 0
Address 36036 0
Country 36036 0
Phone 36036 0
Fax 36036 0
Email 36036 0
Contact person for public queries
Name 9854 0
Ms Susan Lee
Address 9854 0
University Department of Paediatrics
The Women's and Children's Hospital
72 King William Rd
North Adelaide SA 5006
Country 9854 0
Australia
Phone 9854 0
+61 8 81616228
Fax 9854 0
+61 8 81617031
Email 9854 0
[email protected]
Contact person for scientific queries
Name 782 0
Dr Patrick Quinn
Address 782 0
University Department of Paediatrics
The Women's and Children's Hospital
72 King William Rd
North Adelaide SA 5006
Country 782 0
Australia
Phone 782 0
+61 8 81617266
Fax 782 0
+61 8 81617031
Email 782 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.