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

NCT00854958 | Completed

• 1 other identifier: 05/Q0404/38
• Study Type: observational
• Target: 123
• Locations: 1 country
• Sites: 1

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.

Conditions

Food Allergy

Keywords

Oral; Allergy; Syndrome; Food; Pollen

Outcome Measures

Primary Outcomes (1)

• The validation of the OAS diagnostic questionnaire (PFSDQ) against accepted standard methods of diagnosis.

  18 months

Secondary Outcomes (1)

• The characterisation of the pollen and aeroallergen sensitivities of those diagnosed with roal allergy syndrome

  18 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult subjects aged over 18 years recruited from the general population

You may qualify if:

• symptoms of seasonal allergic rhino-conjunctivitis with/without seasonal asthma from March to May

You may not qualify if:

• 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.

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead

Study Sites (1)

Royal Brompton & Harefield NHS Trust

London, SW3 6NP, United Kingdom

Location

Related Publications (1)

• Skypala IJ, Calderon MA, Leeds AR, Emery P, Till SJ, Durham SR. Development and validation of a structured questionnaire for the diagnosis of oral allergy syndrome in subjects with seasonal allergic rhinitis during the UK birch pollen season. Clin Exp Allergy. 2011 Jul;41(7):1001-11. doi: 10.1111/j.1365-2222.2011.03759.x. Epub 2011 Apr 25.

  PMID: 21518043 DERIVED

MeSH Terms

Conditions

Food Hypersensitivity; Hypersensitivity; Syndrome

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Immune System Diseases; Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephen R Durham, BA, MA, MD,

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 2, 2009
• First Posted: March 3, 2009
• Study Start: May 1, 2005
• Primary Completion: September 1, 2006
• Study Completion: September 1, 2007
• Last Updated: March 3, 2009

Record last verified: 2009-02

Locations

GB (1)