Allergic RhinitisNCT00787631
Analysis of Immunological Reactions to Foods in Birch Pollen-Allergic Patients
An observational study of Allergic Rhinitis and Food Allergy, run by Medical University of Vienna.
Trial summary
A high number of birch pollen-allergic individuals develop hypersensitivity reactions to certain foods, e.g. apples. This food allergy is due to immunological cross-reactivity. Birch pollen-related foods contain proteins, e.g. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Allergic Rhinitis, Food Allergy
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Dec 2008to Dec 2010
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: otherwise healthy birch pollen allergic (rhinoconjunctivitis)persons suffering also from oral allergy syndrome to apple.
Who may be able to join
- Otherwise healthy birch pollen allergic (rhinoconjunctivitis)persons
- Positive SPT and RAST to birch pollen
- Sensitized to Bet v 1
Who cannot join
- Persons suffering from malignancies, autoimmune and cardiopulmonary diseases
- Anemia
- Hyper-IgE syndrome
- Treatment with ß-blockers, permanent treatment with antihistaminics, leucotriene antagonists, corticosteroids
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Analysis of Immunological Reactions to Pollen-Related Foods in Birch Pollen-Allergic Patients
A high number of birch pollen-allergic individuals develop hypersensitivity reactions to certain foods, e.g. apples. This food allergy is due to immunological cross-reactivity. Birch pollen-related foods contain proteins, e.g. Mal d 1 in apple, that are structurally related with the major birch pollen allergen, Bet v 1. Hence IgE antibodies and T lymphocytes specific for Bet v 1 recognize these food proteins which results in activation of the immune system and, consequently, in clinical symptoms.
In the present study the investigators intend to investigate if and how the consumption of birch pollen-related food allergens affects birch pollen allergy. In other words, the investigators are interested to analyse whether Bet v 1-related food allergens activate Bet v 1-specific memory cells and thus, contribute to the maintenance of the pollen allergy outside the pollen season. Data obtained in this study will help to clarify the immunological and clinical role of cross-reactivity between pollen and food allergies and will reveal whether avoidance of such foods should be recommended for the patients. Finally, novel approaches for diagnosis and therapy of pollen-related food allergens can be developed.
- Conditions
- Allergic Rhinitis, Food Allergy
- Keywords
- birch pollen pollen allergy, oral allergy syndrome to apple, cross reactivity, bet v 1, mal d 1
- Medical subject headings
- Rhinitis, Allergic, Food Hypersensitivity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2008 (estimated)
- Study startDec 2008
- Primary completionJan 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Tamar Kinaciyan, Ass Prof MD, Principal investigator, Dept. of Dermatology, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00787631
- Sponsor's protocol ID
- TK01/2008
- Status last verified
- Oct 2008
- First submitted
- 23 Oct 2008
- Last updated
- 7 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Immunological Reactions to Pollen-Related Foods in Birch Pollen-Allergic Patients
- ClinicalTrials.gov ID
- NCT00787631
- Acronym / sponsor ID
- TK01/2008
- Conditions
- Allergic Rhinitis, Food Allergy
- Keywords
- birch pollen pollen allergy, oral allergy syndrome to apple, cross reactivity, bet v 1, mal d 1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Jan 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 7 Nov 2008 (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.
A high number of birch pollen-allergic individuals develop hypersensitivity reactions to certain foods, e.g. apples. This food allergy is due to immunological cross-reactivity. Birch pollen-related foods contain proteins, e.g. Mal d 1 in apple, that are structurally related with the major birch pollen allergen, Bet v 1. Hence IgE antibodies and T lymphocytes specific for Bet v 1 recognize these food proteins which results in activation of the immune system and, consequently, in clinical symptoms.
In the present study the investigators intend to investigate if and how the consumption of birch pollen-related food allergens affects birch pollen allergy. In other words, the investigators are interested to analyse whether Bet v 1-related food allergens activate Bet v 1-specific memory cells and thus, contribute to the maintenance of the pollen allergy outside the pollen season. Data obtained in this study will help to clarify the immunological and clinical role of cross-reactivity between pollen and food allergies and will reveal whether avoidance of such foods should be recommended for the patients. Finally, novel approaches for diagnosis and therapy of pollen-related food allergens can be developed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- otherwise healthy birch pollen allergic (rhinoconjunctivitis)persons suffering also from oral allergy syndrome to apple.
Key inclusion criteria (3 listed)
- Otherwise healthy birch pollen allergic (rhinoconjunctivitis)persons
- Positive SPT and RAST to birch pollen
- Sensitized to Bet v 1
Key exclusion criteria (4 listed)
- Persons suffering from malignancies, autoimmune and cardiopulmonary diseases
- Anemia
- Hyper-IgE syndrome
- Treatment with ß-blockers, permanent treatment with antihistaminics, leucotriene antagonists, corticosteroids
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2008.
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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.
Tamar Kinaciyan, Ass Prof MD principal investigator
Dept. of Dermatology, Medical University of Vienna
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Rhinitis and Food Allergy, run by Medical University of Vienna.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 7 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tamar Kinaciyan, Ass.Prof.MD (+43140400 ext. 7700, tamar.kinaciyan@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 7 Nov 2008.