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Trial registered on ANZCTR


Registration number
ACTRN12607000425493
Ethics application status
Approved
Date submitted
15/08/2007
Date registered
22/08/2007
Date last updated
25/01/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of diallertest® in food intolerant children with and without autistic spectrum disorder (ASD)
Scientific title
Evaluation of diallertest® in food intolerant children with and without autistic spectrum disorder (ASD)
Secondary ID [1] 288414 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Clinical evaluation of Diallertest Patch Test used for diagnosis of delayed hypersensitivity to milk and wheat proteins. Allergen concentration is below TGA requirement for Registration. Product is registered in France and United Arab Emirates.
Product Information Sheet is attached. 2266 0
Condition category
Condition code
Skin 2356 2356 0 0
Other skin conditions
Diet and Nutrition 2357 2357 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Diallertest® allergy patch tests. Three Diallertest® patches will be applied to the skin on the child’s back: one with milk protein, one with wheat protein and a ‘control’ patch with no allergen. The patch will be removed at 48 hours and the site of application examined 24 hours later to record any reaction. A positive reaction consists of a 1-2 cm area of localized redness at the contact site. No itch, pain or discomfort should occur.
Intervention code [1] 1977 0
Diagnosis / Prognosis
Comparator / control treatment
Allergy patch test markers active for wheat and milk protein, and control (placebo), will be use both in the control and active participants.
Control group
Placebo

Outcomes
Primary outcome [1] 3255 0
Removal of patch test
Timepoint [1] 3255 0
48 hours
Secondary outcome [1] 5429 0
Visual reading of patch tests (wheat & milk proteins) in comparison to control patch (placebo). A positive reaction consists of a 1-2 cm area of localized redness at the contact site. No itch, pain or discomfort should occur.
Timepoint [1] 5429 0
72 hours

Eligibility
Key inclusion criteria
Most participants will be recruited from amongst children who have been previously seen at the Allergy Unit and participated in a study of diet and nutrition in children with and without Autistic Spectrum Disorder (X03-0197). Some will be newly recruited from amongst those routinely attending the RPAH Allergy Unit for investigation of symptoms suggestive of non-IgE mediated food intolerances.
Minimum age
3 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children with documented IgE mediated allergies to milk or wheat will be excluded.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2007
Actual
30/08/2007
Date of last participant enrolment
Anticipated
Actual
31/08/2007
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
123
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2513 0
Hospital
Name [1] 2513 0
RPAH Allergy Unit
Country [1] 2513 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Diallertest devices supplied as donation by Nutricia Australia Pty Ltd
Address
Talavera Corporate Centre
Level 4, Building D
12-18 Talavera Rd
Macquarie Park NSW 2113
Country
Australia
Secondary sponsor category [1] 2279 0
None
Name [1] 2279 0
Address [1] 2279 0
Country [1] 2279 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4429 0
Sydney South West Area Health Service NSW Health
Ethics committee address [1] 4429 0
Research Development Office
Level 8, Bldng 14
Royal Prince Alfred Hospital
Camperdown NSW 2050
Ethics committee country [1] 4429 0
Date submitted for ethics approval [1] 4429 0
Approval date [1] 4429 0
30/08/2007
Ethics approval number [1] 4429 0
07/RPAH/22

Summary
Brief summary
The study will evaluate a new skin test device used for the diagnosis of cows’ milk or wheat protein intolerance. Diallertest® is a new type of allergy skin test designed for topical application (‘patch test’). Whereas standard allergy tests (‘skin prick tests’) measure immediate (IgE mediated) immune reactions to food and other allergens, the Diallertest® is intended to measure delayed (T cell mediated) reactions occurring 24-72 hours after exposure.

Most participants will be recruited from amongst children who have been previously seen at the Allergy Unit and participated in a study of diet and nutrition in children with and without Autistic Spectrum Disorder (X03-0197). Some will be newly recruited from amongst those routinely attending the RPAH Allergy Unit for investigation of symptoms suggestive of non-IgE mediated food intolerances. Children with documented IgE mediated allergies to milk or wheat will be excluded.

In order to determine the diagnostic predictive value of Diallertest® in this population, patch test results will be correlated with clinical history, skin prick test results, and oral food challenge results which have been done as part of clinical management. The results may also provide clues as to the mechanisms underlying intolerances to milk and wheat proteins observed in suitably selected children with and without ASD. The feasibility of using digital photography as a means of measuring and recording positive test results will also be evaluated.
Trial website
Trial related presentations / publications
Nil. Diallertest company decided not to publish our findings as they had other studies occurring in other centres
Public notes

Contacts
Principal investigator
Name 27987 0
Dr Velencia Soutter
Address 27987 0
RPAH Allergy Unit 9-11 Layton Street Camperdown NSW 2050
Country 27987 0
Australia
Phone 27987 0
+61417 217 174
Fax 27987 0
Email 27987 0
[email protected]
Contact person for public queries
Name 11144 0
Velencia Soutter
Address 11144 0
RPAH Allergy Unit
9-11 Layton Street
Camperdown NSW 2050
Country 11144 0
Australia
Phone 11144 0
0417 217 174
Fax 11144 0
Email 11144 0
[email protected]
Contact person for scientific queries
Name 2072 0
Velencia Soutter
Address 2072 0
RPAH Allergy Unit
9-11 Layton Street
Camperdown NSW 2050
Country 2072 0
Australia
Phone 2072 0
0417 217 174
Fax 2072 0
Email 2072 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.