Consuming Migo pear without getting allergic symptoms.
ID
Source
Brief title
Condition
- Allergic conditions
- Food intolerance syndromes
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Consuming the hypoallergenic Migo pear without experiencing an allergic
reaction.
Secondary outcome
2. How does the amount of pear, at which the patient experience symptoms,
differ between the Migo pear and the Conference pear?
3. What is the difference in surface area in the skin test between the Migo
pear and the Conference pear?
4. What is the difference in surface area in the skin test between the Migo
pear and Birch pollen?
Background summary
The European Fruit Co-operation (EFC) and Green star-Kanzi Europe NV (GKE NV)
have expressed interest in introducing a hypoallergenic pear crop on the
market. GKE NV is the variety manager of two world famous apple brands; Kanzi
and Greenstar, as well as the pear brand Migo. Some customers who have an apple
allergy, indicate they can eat the Migo pear without it causing allergic
reactions. Wageningen Food & Biobased Research carried out a literature study
on the already completed project *Migo hypoallergenic pear* to describe
background information which will be required to determine the feasibility of
conducting a claim as hypoallergenic pear crop. EFC and GKE NV have expressed
interest to carry out a humane study (skin prick test and prick to prick test
and oral provocation test) to test the hypoallergenic properties of Migo pear
in people.
Study objective
Consuming Migo pear without getting allergic symptoms.
Study design
Observational study with interventions.
Study burden and risks
All participating patients will be administered a questionnaire about the diet
specific history. On day one, a skin test (SPT and PTP) will be carried out. A
single tube of blood will be collected. The patient will visit the hospital
twice for 4 hours for an open provocation with pear, which takes place at the
Allergy Department. A provocation involves risks, but these risks are limited
by starting with the minimal amount of the allergen. The dosage will be
increased gradually. Physical complaints are monitored through a VAS score
list, related to rating provocation (version 14-12-2018). There always will be
a doctor and a nurse present at the Department, emergency medications
(antihistamines, dexamethasone and adrenaline) are syringe ready.
Possible advantage of participation is the possibility to add pear to the often
limited diet or a better estimate of the amount of pear that can be eaten.
Dr. Molenwaterplein 40
Rotterdam 3015 GD
NL
Dr. Molenwaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
Signed informed consent form
18 years of age or older, mentally competent
Patients proven allergic to pear by skin prick test and prick to prick test
(HEP > 0,4)
Diet free of pear, earlier complaints after eating pear.
No use of antihistamines in the last 72 hours before the skin test and the food
challenge with pear.
Exclusion criteria
Patiënt under 18 years, mentally incompetent.
Negative skin prick test and prick to prick test with pear (HEP < 0,4).
Diet not free of pear, eating pear without complaints.
Unable to stop beta blocker
Use of antihistamines in the last 72 hours before the skin prick test and food
challenge with pear
Use of more than 10 mg prednisone (relative contraindication)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL70165.078.19 |