Oral Allergy Syndrome (OAS): a Pilot Study to Evaluate a Clinical Questionnaire as a Diagnostic Tool
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|ClinicalTrials.gov Identifier: NCT00427479|
Recruitment Status : Completed
First Posted : January 29, 2007
Last Update Posted : January 29, 2007
|First Submitted Date||January 26, 2007|
|First Posted Date||January 29, 2007|
|Last Update Posted Date||January 29, 2007|
|Study Start Date||July 2002|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures||Not Provided|
|Original Primary Outcome Measures||Not Provided|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Oral Allergy Syndrome (OAS): a Pilot Study to Evaluate a Clinical Questionnaire as a Diagnostic Tool|
|Official Title||The Prevalence of Oral Allergy Syndrome and Types of Food Commonly Causing Reactions in Birch Pollen Sensitive Patients Who Have Springtime Hayfever|
An increasing number of people have an allergy to birch pollen, which manifests itself as Springtime hayfever. Some will also have cross-reactions to fruits, vegetables and nuts, a condition known as Oral Allergy Syndrome (OAS). Research has demonstrated that the most effective method of diagnosing this problem is by taking a good clinical history and performing skin prick tests using fresh foods.
The aim of the study will be therefore to investigate the prevalence of OAS in a birch-sensitive population using a simple screening tool and establish the range of foods involved. The objective will be to maximise effective treatment for the patients in our large respiratory allergy clinic by using the screening tool to identify patients with OAS and advise them on the usual foods involved. A further objective will be to use the data to discover if there are any patterns of particular foods involved in OAS in UK sufferers.
The study hypotheses are therefore that there is a high prevalence of oral allergy in people with birch pollen allergy; the best way of diagnosing the problem is by using a screening tool and that there is a core set of foods that are commonly involved in OAS in patients seen in the allergy clinic.
Patients will be recruited both prospectively and retrospectively from the Royal Brompton Hospital allergy clinic and through advertisement. Subjects will be identified by diagnosis of birch pollen allergy, either routinely in the RBHT adult allergy clinic or by looking back at patient records. Suitable patients will be invited to participate in the study, with fully informed consent obtained, if they understand written English and fulfil the following criteria:
Criteria for inclusion
After a full explanation of the study given, patients who agree to participate will be asked to sign the consent form, a copy of which will be placed in the medical notes, and a second copy sent to the Ethics Committee Administrator. Participants will then be booked in for visit one and advised to avoid short acting antihistamines for 72 hours and long acting ones for a week, prior to their prick prick test.
The OAS screening tool will be completed for every patient. A venous blood sample will be taken and stored for the measurement of total IgE and specific IgE RAST tests for birch, apple, celery and hazelnuts. A questionnaire will be completed by the patient assessing the effect any food reactions is having on their diet and social life. The researcher will then complete a 24-hour food recall questionnaire with the patient, to ascertain their normal dietary intake.
The patient will then be asked whether they have taken anti-histamines in the last 72 hours, and if they have not then prick prick tests can be performed using a range of different fresh fruits, vegetables, nuts and Birch and Grass reagent. The tests will be undertaken according to EAACI recommendations, with a positive and negative control. The allergen content of fresh foods is unknown, but using data from previous studies, a wheal of 3mm will be considered positive, and a wheal of 5 mm strongly positive.
All participants will then be invited to return to undergo one single blind, placebo food challenge. Those classed as negative responders will then undergo two double blind, placebo-controlled food challenges (DBPCFC), one being an active substance and one a control substance. Following these challenges, those still classed as negative responders will undergo an open challenge with the active substance. The only exclusion criteria will be those subjects who have previously reported an anaphylactic response to the active challenge material.
|Study Design||Observational Model: Case Control
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Study Groups/Cohorts||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Original Enrollment||Same as current|
|Study Completion Date||December 2003|
|Primary Completion Date||Not Provided|
|Ages||16 Years and older (Child, Adult, Older Adult)|
|Accepts Healthy Volunteers||Yes|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||United Kingdom|
|Removed Location Countries|
|Other Study ID Numbers||2002UR005B|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor||Royal Brompton & Harefield NHS Foundation Trust|
|PRS Account||Royal Brompton & Harefield NHS Foundation Trust|
|Verification Date||January 2007|