The Diagnosis of Oral Allergy Syndrome Through the Use of a Structured Questionnaire
March 2, 2009 updated by: Royal Brompton & Harefield NHS Foundation Trust
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
123
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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London, United Kingdom, SW3 6NP
- Royal Brompton & Harefield NHS Trust
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Adult subjects aged over 18 years recruited from the general population
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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The validation of the OAS diagnostic questionnaire (PFSDQ) against accepted standard methods of diagnosis.
Time Frame: 18 months
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18 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The characterisation of the pollen and aeroallergen sensitivities of those diagnosed with roal allergy syndrome
Time Frame: 18 months
|
18 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Stephen R Durham, BA, MA, MD,, Imperial College London
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2005
Primary Completion (Actual)
September 1, 2006
Study Completion (Actual)
September 1, 2007
Study Registration Dates
First Submitted
March 2, 2009
First Submitted That Met QC Criteria
March 2, 2009
First Posted (Estimate)
March 3, 2009
Study Record Updates
Last Update Posted (Estimate)
March 3, 2009
Last Update Submitted That Met QC Criteria
March 2, 2009
Last Verified
February 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05/Q0404/38
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.