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

NCT ID: NCT00854958

Last Updated: 2009-03-03

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

Total Enrollment

123 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-05-31

Study Completion Date

2007-09-30

Brief Summary

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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

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Conditions

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Food Allergy

Study Design

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Observational Model Type

COHORT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Royal Brompton & Harefield NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Royal Brompton & Harefield NHS Trust

Principal Investigators

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Stephen R Durham, BA, MA, MD,

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

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Royal Brompton & Harefield NHS Trust

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Skypala IJ, Calderon MA, Leeds AR, Emery P, Till SJ, Durham SR. Development and validation of a structured questionnaire for the diagnosis of oral allergy syndrome in subjects with seasonal allergic rhinitis during the UK birch pollen season. Clin Exp Allergy. 2011 Jul;41(7):1001-11. doi: 10.1111/j.1365-2222.2011.03759.x. Epub 2011 Apr 25.

Reference Type DERIVED
PMID: 21518043 (View on PubMed)

Other Identifiers

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05/Q0404/38

Identifier Type: -

Identifier Source: org_study_id

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