Food AllergyNCT00854958
The Diagnosis of Oral Allergy Syndrome Through the Use of a Structured Questionnaire
An observational study of Food Allergy, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Food Allergy
- How many people
- 123 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2005to Sep 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult subjects aged over 18 years recruited from the general population
Who may be able to join
- symptoms of seasonal allergic rhino-conjunctivitis with/without seasonal asthma from March to May
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Brompton & Harefield NHS Trust
London, SW3 6NP
About this study
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
- Medical subject headings
- Food Hypersensitivity, Hypersensitivity, Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
The validation of the OAS diagnostic questionnaire (PFSDQ) against accepted standard methods of diagnosis.
Measured: 18 months
Secondary outcomes (1)
The characterisation of the pollen and aeroallergen sensitivities of those diagnosed with roal allergy syndrome
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2009 (estimated)
- Study startMay 2005
- Primary completionSep 2006
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Investigators
- Stephen R Durham, BA, MA, MD,, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00854958
- Sponsor's protocol ID
- 05/Q0404/38
- Status last verified
- Feb 2009
- First submitted
- 2 Mar 2009
- Last updated
- 3 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21518043
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnosis of Oral Allergy Syndrome Through the Use of a Structured Questionnaire
- ClinicalTrials.gov ID
- NCT00854958
- Acronym / sponsor ID
- 05/Q0404/38
- Conditions
- Food Allergy
- Keywords
- Oral, Allergy, Syndrome, Food, Pollen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 3 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects aged over 18 years recruited from the general population
Key inclusion criteria (1 listed)
- symptoms of seasonal allergic rhino-conjunctivitis with/without seasonal asthma from March to May
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The validation of the OAS diagnostic questionnaire (PFSDQ) against accepted standard methods of diagnosis.
Time frame: 18 months
1 secondary outcome
The characterisation of the pollen and aeroallergen sensitivities of those diagnosed with roal allergy syndrome
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2009.
- Derived from this study: PubMed 21518043Skypala 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen R Durham, BA, MA, MD, principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Food Allergy, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The validation of the OAS diagnostic questionnaire (PFSDQ) against accepted standard methods of diagnosis. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00854958, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2009.