MedPath

The Flake Study: a study trying to answer the question of whether children with fish allergy can eat flake safely.

Conditions
Food Allergy
Inflammatory and Immune System - Allergies
Registration Number
ACTRN12619000111178
Lead Sponsor
Dr Sam Mehr
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot yet recruiting
Sex
All
Target Recruitment
35
Inclusion Criteria

Patients aged between 1-18 with a previously diagnosed white fish allergy.

Exclusion Criteria

Physician diagnosed flake allergy.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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, <br><br>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. <br>[Two weeks after oral food challenge to flake.]
Secondary Outcome Measures
NameTimeMethod
To evaluate a novel immunoblot assay in the diagnosis of fish allergy.<br><br>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.[12 months following completion of recruitment. ];To evaluate a homogenised fresh skin prick extract for flake in the diagnosis of flake allergy.<br><br>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). [12 months following completion of recruitment]
© Copyright 2025. All Rights Reserved by MedPath