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Trial registered on ANZCTR


Registration number
ACTRN12619000111178p
Ethics application status
Submitted, not yet approved
Date submitted
17/01/2019
Date registered
24/01/2019
Date last updated
24/01/2019
Date data sharing statement initially provided
24/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Flake Study: a study trying to answer the question of whether children with fish allergy can eat flake safely.
Scientific title
The Flake Study: Investigating the rate of flake co-allergy in fish allergic children
Secondary ID [1] 297123 0
Nil known
Universal Trial Number (UTN)
U1111-1226-9236
Trial acronym
Nil known
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Food Allergy 311141 0
Condition category
Condition code
Inflammatory and Immune System 309772 309772 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We propose to challenge 35 children and adolescents with fish allergy with flake to ascertain the rate of flake allergy in this cohort.

The intervention in this case is an oral food challenge to flake (gummy shark). Challenge will be conducted according to the ASCIA standard food challenge protocol, using incremental dosing of cooked gummy shark up to a total dose of 100 grams of gummy shark (a standard serve size; equivalent to 21 grams of protein). The gummy shark will be sourced and cooked by the patients themselves (as per standard clinical practice for food challenges) weighed prepared by the study nurses on the day of challenge. The increments (in grams of total gummy shark), which will be given every 20 min, and include: touch to the lip, 0.5g, 1.4g. 4.8g.14.3g.28.5g and rest of the fish (approximately 52g) equating to 21g of actual fish protein in total. The food challenge to gummy shark will proceed regardless of the size of the skin test to gummy shark. Cumulative and eliciting threshold doses will be recorded in grams of gummy shark ingested. A challenge will be deemed positive and stopped according to the PRACTALL criteria. PRACTALL is a European/North American co-operative of allergist and immunologists that provide consensus statements regarding best practice, including the OFC procedure, within the discipline.

Our Immunology Fellow and an Allergy nurse will be performing the oral food challenges. A Consultant Allergist/Immunologist will always be present at the time of the challenge. The estimated total time commitment for the visit is between 4-6hrs. Patients who successfully passed the challenge will be asked to eat two serves (approximately 2 teaspoons of flake per serve) of flake per week for the following two weeks. It is well established that failure to re-incorporate a food post successful OFC can potentially lead to recurrence of the allergy. However, it remains unclear just how frequent the food needs to be consumed in order to maintain tolerance. Serving suggestions of 1-2 times a week are consistent with standard clinical practice in the absence of clear, empirical evidence.

All patients will be contacted via phone 2 weeks following the challenge to ensure patient welfare and protocol adherence. If any post challenge reactions occur in that period or at any period following completion of the study, they will be seen at Epworth Allergy Specialists free of charge. After the initial post-challenge follow up period, participants who successfully pass the challenge will be advised to incorporate flake that they source directly, rather than purchased at a restaurant, in order to minimise the risk of inadvertent exposure particularly if allergic to another species of white fish. Participants who react to the gummy shark during the challenge will be advised to strictly avoid gummy shark. The total time period of the proposed intervention from oral food challenge to phone follow up is two weeks.

We will also trial a skin prick test extract and immunoblot assay on patient serum to help refine the diagnosis of flake allergy. This involves administration of a standard skin prick test, according to the procedures outlined in the ASCIA manual for skin prick testing, using frozen, blended fresh flake extract prepared by James Cook University. Fresh food skin prick testing is commonly used in clinical practice in the diagnosis of food allergy.
Intervention code [1] 313388 0
Diagnosis / Prognosis
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 318730 0
To ascertain the rate of allergy to flake (gummy shark) in children with a pre-existing white fish allergy. Tolerance of flake is defined as the ability to pass an oral food challenge during the day admission and then continue to eat flake for a two week period following the challenge,

Passing a food challenge equates to the ability to eat a serving of flake (2 teaspoons) without any allergic symptoms as outlined by the PRACTALL criteria for oral food challenges.
Timepoint [1] 318730 0
Two weeks after oral food challenge to flake.
Secondary outcome [1] 365840 0
To evaluate a novel immunoblot assay in the diagnosis of fish allergy.

The composite outcome of sensitivity and specificity of the immunoblot will be calculated based upon the proportion of children who pass the oral food challenge to flake. This immunoblot uses a immunoflurescence based to measure serum specific IgE reactivity to the flake protein.
Timepoint [1] 365840 0
12 months following completion of recruitment.
Secondary outcome [2] 366064 0
To evaluate a homogenised fresh skin prick extract for flake in the diagnosis of flake allergy.

The composite outcome of sensitivity and specificity of the extract will be calculated based upon the proportion of children who pass the oral food challenge to flake. A positive skin test represents a wheal that is greater than or equal to 3mm. or greater than the histamine control (usually greater than 3mm).
Timepoint [2] 366064 0
12 months following completion of recruitment

Eligibility
Key inclusion criteria
Patients aged between 1-18 with a previously diagnosed white fish allergy.
Minimum age
1 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Physician diagnosed flake allergy.

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/02/2019
Actual
Date of last participant enrolment
Anticipated
5/02/2020
Actual
Date of last data collection
Anticipated
19/02/2020
Actual
Sample size
Target
35
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 12942 0
Epworth Richmond - Richmond
Recruitment hospital [2] 12943 0
Epworth Hospital Geelong - Waurn Ponds
Recruitment postcode(s) [1] 25416 0
3121 - Richmond
Recruitment postcode(s) [2] 25417 0
3216 - Waurn Ponds

Funding & Sponsors
Funding source category [1] 301684 0
Charities/Societies/Foundations
Name [1] 301684 0
Epworth Medical Foundation
Country [1] 301684 0
Australia
Primary sponsor type
Individual
Name
Dr Sam Mehr
Address
c/o Epworth Allergy Specialists
34 Erin Street
Richmond, VIC 3121
Country
Australia
Secondary sponsor category [1] 301404 0
None
Name [1] 301404 0
Address [1] 301404 0
Country [1] 301404 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 302404 0
MonashHealth HREC
Ethics committee address [1] 302404 0
Ethics committee country [1] 302404 0
Australia
Date submitted for ethics approval [1] 302404 0
16/01/2019
Approval date [1] 302404 0
Ethics approval number [1] 302404 0

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

Contacts
Principal investigator
Name 90122 0
Dr Sam Mehr
Address 90122 0
Epworth Allergy Specialists
34 Erin Street
Richmond VIC 3121
Country 90122 0
Australia
Phone 90122 0
+61 3 4626 6888
Fax 90122 0
Email 90122 0
sam.mehr@rch.org.au
Contact person for public queries
Name 90123 0
John Ainsworth
Address 90123 0
Epworth Allergy Specialists
34 Erin Street
Richmond, VIC 3121
Country 90123 0
Australia
Phone 90123 0
+61 3 94266888
Fax 90123 0
Email 90123 0
john.ainsworth@epworth.org.au
Contact person for scientific queries
Name 90124 0
John Ainsworth
Address 90124 0
Epworth Allergy Specialists
34 Erin Street
Richmond, VIC 3121
Country 90124 0
Australia
Phone 90124 0
+61 3 4626 6888
Fax 90124 0
Email 90124 0
john.ainsworth@epworth.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1097Study protocol    376766-(Uploaded-17-01-2019-14-16-20)-Study-related document.docx



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.