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The Diagnosis of Oral Allergy Syndrome Through the Use of a Structured Questionnaire
This study has been completed.
First Received: March 2, 2009   No Changes Posted
Sponsored by: Royal Brompton & Harefield NHS Foundation Trust
Information provided by: Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00854958
  Purpose

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
Food Allergy

Study Type: Observational
Study Design: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The characterisation of the pollen and aeroallergen sensitivities of those diagnosed with roal allergy syndrome [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Adult subjects aged over 18 years recruited from the general population

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00854958

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

No publications provided

Responsible Party: Royal Brompton & Harefield NHS Trust ( Isabel Skypala, Director of Rehabilitation and Therapies )
Study ID Numbers: 05/Q0404/38
Study First Received: March 2, 2009
Last Updated: March 2, 2009
ClinicalTrials.gov Identifier: NCT00854958     History of Changes
Health Authority: United Kingdom: National Health Service

Keywords provided by Royal Brompton & Harefield NHS Foundation Trust:
Oral
Allergy
Syndrome
Food
Pollen

Study placed in the following topic categories:
Food Hypersensitivity
Hypersensitivity
Hypersensitivity, Immediate

Additional relevant MeSH terms:
Food Hypersensitivity
Hypersensitivity
Pathologic Processes
Disease
Immune System Diseases
Syndrome
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on September 11, 2009