Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00854958
Other study ID # 05/Q0404/38
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Withdrawn NCT03089476 - Evaluating Skin Barrier Dysfunction in Infants at High Risk of Atopy N/A
Recruiting NCT05839405 - Food Allergy in the Brain
Completed NCT02552537 - iFAAM: The Impact of Proton-pump Inhibitors (Antacids) on Threshold Dose Distributions Phase 4
Completed NCT01634737 - Crustacean Allergy and Dust Mites Sensitization N/A
Recruiting NCT05521711 - TRADE Trial - Tree Nut Immunotherapy Route Development and Evaluation N/A
Completed NCT05072665 - Fast Allergy Sensitivity Test N/A
Active, not recruiting NCT04887441 - Allergology: Information, Data and Knowledge Organization
Recruiting NCT03265262 - The Basophil Activation Test as a Diagnostic Tool in Pediatric Food Allergy N/A
Completed NCT04186949 - Early Origins of Allergy and Asthma
Completed NCT02490007 - Pertussis Immunisation and Food Allergy
Recruiting NCT03151252 - Improvement of Foodallergy Diagnostic in Gastrointestinal Tract N/A
Completed NCT02159833 - Intranasal Diagnostics in Food Allergy: a Feasibility Study N/A
Completed NCT02377284 - Prevention and Management of Food Allergies N/A
Completed NCT02354729 - Encouraging Allergic Young Adults to Carry Epinephrine N/A
Completed NCT02640560 - One-year Survey of Anaphylaxis in Outpatient Children Allergic to Peanuts, Walnuts/Hazelnuts, Shellfish N/A
Enrolling by invitation NCT06097572 - Improved Diagnostics in Food Allergy Study N/A
Recruiting NCT04606615 - Skin Barrier Abnormalities and Oxidative Stress Response
Recruiting NCT05785299 - Clinical Versus Home Introduction of Milk in Children With Non-IgE-mediated Cow's Milk Allergy N/A
Not yet recruiting NCT06112873 - Quality of Life in Food Allergy: Validation of Three Mini-questionnaires
Completed NCT03337802 - Effect of Mediterranean Diet During Pregnancy on the Onset of Overweight and Obesity in the Offspring N/A