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

This study has been completed.
Information provided by:
Royal Brompton & Harefield NHS Foundation Trust Identifier:
First received: March 2, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
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.

Food Allergy

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: The Diagnosis of Oral Allergy Syndrome Through the Use of a Structured Questionnaire

Resource links provided by NLM:

Further study details as provided by Royal Brompton & Harefield NHS Foundation Trust:

Primary Outcome Measures:
  • The validation of the OAS diagnostic questionnaire (PFSDQ) against accepted standard methods of diagnosis. [ Time Frame: 18 months ]

Secondary Outcome Measures:
  • The characterisation of the pollen and aeroallergen sensitivities of those diagnosed with roal allergy syndrome [ Time Frame: 18 months ]

Enrollment: 123
Study Start Date: May 2005
Study Completion Date: September 2007
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Adult subjects aged over 18 years recruited from the general population

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.
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Please refer to this study by its identifier: NCT00854958

United Kingdom
Royal Brompton & Harefield NHS Trust
London, United Kingdom, SW3 6NP
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
Principal Investigator: Stephen R Durham, BA, MA, MD, Imperial College London
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Isabel Skypala, Director of Rehabilitation and Therapies, Royal Brompton & Harefield NHS Trust Identifier: NCT00854958     History of Changes
Other Study ID Numbers: 05/Q0404/38
Study First Received: March 2, 2009
Last Updated: March 2, 2009

Keywords provided by Royal Brompton & Harefield NHS Foundation Trust:

Additional relevant MeSH terms:
Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate processed this record on September 21, 2017