Intranasal Diagnostics in Food Allergy: a Feasibility Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2019-01-04

Brief Summary

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The investigators will conduct low-dose intranasal allergen challenges on children/adolescents with a diagnosis of food allergy to egg/cow's milk/soya/wheat/peanut. The data will be used to determine the safety and potential utility of intranasal food challenges in the diagnosis of food allergy.

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Detailed Description

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Conditions

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Food Allergy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Intervention

Intranasal challenge with food protein or vehicle control

Group Type EXPERIMENTAL

Intranasal challenge with active substance (food protein)

Intervention Type OTHER

Intranasal challenge with placebo

Intervention Type OTHER

Interventions

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Intranasal challenge with active substance (food protein)

Intervention Type OTHER

Intranasal challenge with placebo

Intervention Type OTHER

Other Intervention Names

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placebo = 0.9% NaCl saline solution

Eligibility Criteria

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Inclusion Criteria

* Aged 6 - 17 years old
* Physician-diagnosis of food allergy on the basis of:

* Positive oral food challenge to the causative food (conducted under medical supervision) within the last 12 months; OR
* History of convincing clinical reaction to the causative food within the last 12 months AND positive skin prick test within last 12 months; OR
* Evidence of \>95% likelihood of food allergy (on the basis of serum specific IgE or skin prick test (SPT) 8mm or above to the causative food allergen within past 12 months
* Written informed consent from parent/guardian, with assent from children aged 8 years and above wherever possible. Participants aged over 16 years will need to provide their owned informed consent.

Exclusion Criteria

* Contraindicated as acutely unwell or current unstable asthma:

* Acute wheeze in last 72 hours requiring treatment
* Febrile ≥38.0oC in last 72 hours
* Recent admission to hospital in last 2 weeks for acute asthma
* Current medication

* Use of asthma reliever medication in last 72 hours
* Recent administration of a medication containing antihistamine within the last 4 days
* Current oral steroid for asthma exacerbation or course completed within last 2 weeks

Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No