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Completed

NCT Number: NCT00854958

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Brompton & Harefield NHS Trust

London, SW3 6NP, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. The validation of the OAS diagnostic questionnaire (PFSDQ) against accepted standard methods of diagnosis.

    Time frame: 18 months

Secondary outcomes

  1. The characterisation of the pollen and aeroallergen sensitivities of those diagnosed with roal allergy syndrome

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

Royal Brompton & Harefield NHS Foundation Trust

Other

Registry information

Important dates

Study start
2005
Primary completion
2006
Study completion
2007
First posted
Mar 3, 2009
Registry last updated
Mar 3, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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