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Can we Help People With the Oral Allergy Syndrome Eat Fresh Fruit?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01431859
Recruitment Status : Unknown
Verified April 2016 by Nicola Gray, Royal Sussex County Hospital.
Recruitment status was:  Active, not recruiting
First Posted : September 12, 2011
Last Update Posted : April 6, 2016
Information provided by (Responsible Party):
Nicola Gray, Royal Sussex County Hospital

Brief Summary:
Birch pollen allergy is increasingly common. It causes asthma and early season hay fever. This is because the body recognises birch pollen and reacts to it, leading to symptoms. Many patients with birch allergy get an itchy and/or swollen mouth when they eat fresh fruit (apples, pears, peaches, plums etc). Some fruit proteins have a similar structure to birch pollen; because of this the body recognises these proteins too causing the immune system to respond. This response causes symptoms of itch and swelling inside the mouth and throat. the investigators want to find out whether it is possible to get rid of the fruit-induced symptoms by using a desensitisation procedure that has been developed for treating the kind of hay fever that is caused by birch pollen. Desensitisation involves giving a small injection of pollen just under the skin and gradually increasing the amount each week. This allows the body to build up a "tolerance" to the injected protein. When the pollen is then encountered in real life the immune system reacts less vigorously so symptoms are less severe. This treatment does reduce hay fever symptoms. Our study aims to find out if this tolerance is transferred to the fruit proteins enabling patients to eat apples with minimal symptoms. Patients will be given apple to eat in a hidden form before treatment and their response assessed. They will then receive either active or dummy pollen injections before birch pollen season. A few months after completing these injections they will have another disguised apple test to see whether their symptoms are any better. If symptoms have improved with treatment then this therapy could be offered to patients in the future. This would allow them to eat fresh fruit without worrying about unpleasant symptoms and improve their hay fever symptoms.

Condition or disease Intervention/treatment Phase
Oral Allergy Syndrome Biological: Allergovit Birch pollen Other: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Double Blind Placebo Controlled Randomised Trial to Study the Effects of Birch Pollen Specific Immunotherapy (BP-SIT) on the Symptoms of the Oral Allergy Syndrome in Adult Patients
Study Start Date : July 2012
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
Drug Information available for: Bee pollen

Arm Intervention/treatment
Placebo Comparator: Subcutaneous injection of placebo Other: Placebo
Placebo injection to be given subcutaneously once weekly for 7 weeks prior to birch pollen season for 2 consecutive years.

Active Comparator: Birch pollen immunotherapy Biological: Allergovit Birch pollen
Birch pollen specific immunotherapy. Once weekly injection for 7 weeks prior to birch pollen season for 2 consecutive seasons

Primary Outcome Measures :
  1. Change in threshold for eating uncooked apple from baseline, compared to 1 year and 2 years following the intervention. [ Time Frame: baseline, 1 year and 2 years ]

    Baseline measurements will be taken in Winter 2012 assessing the tolerance to fresh apple in a double blind placebo controlled manner. The intervention will start in January 2013.

    Outcomes will be assessed using the double blind placebo controlled food challenge technique in Winter 2013 and 2014. (1 and 2 years after baseline assessment)

Secondary Outcome Measures :
  1. Change in symptoms of rhinoconjunctivitis immediately after the first season of immunotherpay compared to 2 seasons of immunotherapy treatment. [ Time Frame: baseline, 1 year and 2 years ]
    Diary cards will be given to patients to complete in the first season following immunotherapy, to assess hay fever symptoms.

  2. Change in conjunctival provocation tests from baseline. [ Time Frame: baseline, 1 year and 2 years ]
    Conjunctival provocation testing will take place at baseline in Winter 2012 using standard birch pollen exracts. Repeat tests will occur Winter 2013 and 2014 to assess changes following the intervention.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female; age 18 with no upper age limit
  • 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
  • History of spring rhinitis hay fever
  • Positive skin prick test to birch pollen
  • Positive open food challenge to apple

Exclusion Criteria:

  • Significant medical conditions that may affect the risks of giving BP-SIT (especially uncontrolled asthma or ongoing need for beta-blockers)
  • History of moderate to severe systemic reaction to apple, defined as any of: generalised urticaria, generalised angioedema, history convincing for laryngeal oedema, collapse
  • Current immunological disease (auto-immune or thyroid disease, immunodeficiency)
  • 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)
  • Inability to attend regularly for injections and follow-up visits
  • Severe atopic dermatitis
  • Previous immunotherapy with birch pollen extract
  • Pregnant or not using adequate contraception (post-menopausal, surgically sterilised, long-term abstinent, or barrier methods plus spermicide)
  • Breast-feeding
  • Evidence of current drug or alcohol misuse

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01431859

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United Kingdom
Royal Sussex County Hospital
Brighton, East Sussex, United Kingdom, BN2 5BE
Sponsors and Collaborators
Royal Sussex County Hospital
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Principal Investigator: Anthony Frew, MBBS MD FRCP Brighton and Sussex University Hospital Trust

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Responsible Party: Nicola Gray, Clinical Research Fellow, Royal Sussex County Hospital Identifier: NCT01431859    
Other Study ID Numbers: 10/143/FREW
2011-004078-26 ( EudraCT Number )
First Posted: September 12, 2011    Key Record Dates
Last Update Posted: April 6, 2016
Last Verified: April 2016
Keywords provided by Nicola Gray, Royal Sussex County Hospital:
Additional relevant MeSH terms:
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Pathologic Processes
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs