Can we help people with Oral Allergy Syndrome eat fresh fruit?

Not Applicable

Completed

• Conditions: Topic: Primary Care Research Network for England, Inflammatory and Immune System, Respiratory; Subtopic: Not Assigned, Inflammatory and Immune System (all Subtopics), Respiratory (all Subtopics); Disease: Immunology and inflammation, Respiratory, All Diseases; Injury, Occupational Diseases, Poisoning; Other adverse food reactions, not elsewhere classified

• Registration Number: ISRCTN01027357
• Lead Sponsor: Brighton and Sussex University Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-10-04
• Study Completion: 2017-01-31
• Last Update Posted: 19 April 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. Male or female; age 18 with no upper age limit
2. History of typical fruit-related symptoms on eating apples plus or minus other plant-derived foods known to be involved in the pollen-food syndrome
3. History of spring rhinitis hay fever
4. Positive skin prick test to birch pollen
5. Positive open food challenge to apple

Exclusion Criteria

1. Inadequately controlled or moderate to severe asthma (GINA III/IV), i.e. the FEV1 is below 70 % of the target value despite adequate pharmacotherapy
2. Irreversible changes in the reaction organ (emphysema, bronchiectasis, etc.)
3. Clinically significant cardiovascular insufficiency (in cardiovascular diseases, there is an elevated risk of adverse reactions to adrenaline)
4. Local or systemic use of beta blockers
5. History of moderate to severe systemic reaction to apple, defined as any of: generalised urticaria, generalised angioedema, history convincing for laryngeal oedema, collapse
6. Diseases of the immune system (autoimmune diseases, immune complex-induced immunopathies, immunodeficiencies etc.)
7. Malignant disease within the past five years (Patients with previous malignant disease that is considered cured may be included subject to the consent of their oncologist)
8. Inability to attend regularly for injections and follow-up visits
9. Severe atopic dermatitis
10. Previous immunotherapy with birch pollen extract
11. Pregnant or not using adequate contraception (post-menopausal, surgically sterilised, long-term abstinent, or barrier methods plus spermicide)
12. Breast-feeding
13. Evidence of current drug or alcohol misuse
14. Hypersensitivity to any of the BP-SIT exipients
15. Active tuberculosis
16. Severe mental disorders
17. Multiple sclerosis
18. Patients with an acute febrile illness should not be included in the study but they may take part once they have recovered.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A change in tolerance to fresh apple, 1 year and 2 years post immunotherapy

Secondary Outcome Measures

Name	Time	Method
o secondary outcome measures