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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00854958
Recruitment Status : Completed
First Posted : March 3, 2009
Last Update Posted : March 3, 2009
Information provided by:
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.

Condition or disease
Food Allergy

Study Type : Observational
Actual Enrollment : 123 participants
Observational Model: Cohort
Official Title: The Diagnosis of Oral Allergy Syndrome Through the Use of a Structured Questionnaire
Study Start Date : May 2005
Actual Primary Completion Date : September 2006
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

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
First Posted: March 3, 2009    Key Record Dates
Last Update Posted: March 3, 2009
Last Verified: February 2009

Keywords provided by Royal Brompton & Harefield NHS Foundation Trust:

Additional relevant MeSH terms:
Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate