The Diagnosis of Oral Allergy Syndrome Through the Use of a Structured Questionnaire

Completed

• Conditions: Food Allergy

• Registration Number: NCT00854958
• Lead Sponsor: Royal Brompton & Harefield NHS Foundation Trust

Brief Summary

Oral allergy syndrome is a type of food allergy which mainly affects people with springtime hay fever. It is caused by a cross-reaction, between antibodies to pollens, usually birch tree pollen, and allergens in many different plant foods. It is characterised by symptoms of itching and/or swelling in the mouth and/or throat when eating certain fruits vegetables and nuts. Many of the allergens causing OAS are destroyed by heat, making allergy testing using traditional allergen extracts unreliable. Prick testing or challenging with fresh foods is more reliable, but time consuming, inconvenient and largely unavailable. Pilot study results suggest the characteristic symptoms and foods involved in OAS allow accurate diagnosis using clinical history alone, which forms the basis for the hypothesis of this proposal that OAS can be diagnosed accurately by use of a validated questionnaire alone. The diagnostic questionnaire (PFSDQ), revised from the results of the pilot study, will be tested against two reference test methods, the gold standard of oral food challenge, and the 'platinum standard' of diagnosis made by a medical expert based on history, skin prick testing and oral food challenge. This is not an epidemiological study but with no published studies on OAS in a UK population, this study will also provide some information on the prevalence of OAS in those with springtime hayfever in the UK.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Primary Completion: 2006-09
• Study Completion: 2007-09
• Status Verified: 2009-02
• Study First Submitted: 2009-03-02
• Study First Submitted QC: 2009-03-02
• Last Update Submitted: 2009-03-02
• Study First Posted: 2009-03-03
• Last Update Posted: 2009-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

Inclusion Criteria

• symptoms of seasonal allergic rhino-conjunctivitis with/without seasonal asthma from March to May

Exclusion Criteria

• below the age of 18 years, had poorly controlled concomitant asthma (Forced Expiratory Volume in one second (FEV1) <70% predicted), any significant pre-existing medical condition, were pregnant or required β-blocking agents, H1-receptor antagonists or glucocorticosteroids on a continuous basis.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The validation of the OAS diagnostic questionnaire (PFSDQ) against accepted standard methods of diagnosis.	18 months

Secondary Outcome Measures

Name	Time	Method
The characterisation of the pollen and aeroallergen sensitivities of those diagnosed with roal allergy syndrome	18 months

Trial Locations

Locations (1)

Royal Brompton & Harefield NHS Trust; 🇬🇧 London, United Kingdom