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

Food Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00854958
• Other study ID #: 05/Q0404/38
• Status: Completed
• Phase: N/A
• First received: March 2, 2009
• Last updated: March 2, 2009
• Start date: May 2005
• Est. completion date: September 2007

Study information

• Verified date: February 2009
• Source: Royal Brompton & Harefield NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: September 2007
• Est. primary completion date: September 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 ß-blocking agents, H1-receptor antagonists or glucocorticosteroids on a continuous basis.

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Food Allergy
• Food Hypersensitivity
• Hypersensitivity

Locations

Country	Name	City	State
United Kingdom	Royal Brompton & Harefield NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Royal Brompton & Harefield NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The validation of the OAS diagnostic questionnaire (PFSDQ) against accepted standard methods of diagnosis.		18 months	No
Secondary	The characterisation of the pollen and aeroallergen sensitivities of those diagnosed with roal allergy syndrome		18 months	No