Establishing an eliciting dose distribution for walnut on population level by determining individual eliciting doses in double-blind placebo controlled food challenges.
ID
Source
Brief title
Condition
- Allergic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Establishing an eliciting dose distribution for walnut on population level by
determining individual eliciting doses in double-blind placebo controlled food
challenges.
Secondary outcome
Identifying biomarkers that play a role in a food allergic reaction.
Background summary
Most patients with food allergy adhere strictly to their diet to avoid the
relevant food. Therefore, most reactions take place by hidden allergens or
suboptimal labeling of food products. Good labeling is essential in preventing
food allergic reactions. The current legislation is inadequate.
A first step in improving laws and regulations is to
quantify the effects of certain concentrations of allergens in products. This
requires knowledge of eliciting doses. The eliciting dose is defined as the
lowest amount of allergen that is required to elicit an allergic reaction and
is derived from double-blind placebo-controlled food challenges which are also
used in routine daily practice to diagnose a food allergy.
At this moment, eliciting doses for some well-known food
products that can trigger an allergic reaction (peanut, hazelnut, milk, egg)
have been established by food challenges in representative populations. For
walnut these data are still lacking while it is the third most common food
allergy in the Netherlands and the fourt most common in Europe.
Study objective
Establishing an eliciting dose distribution for walnut on population level by
determining individual eliciting doses in double-blind placebo controlled food
challenges.
Study design
Visit 1: characterization of patients by skin prick test and blood tests
Visit 2 and 3: food challenge
Visit 4 (only in case of a positive food challenge and after particular
informed consent for this extra visit): blood withdrawal
Intervention
Food challenge with walnut food for all participants
Study burden and risks
First visit: 1 hour and 2 provocation days of each 8 hours, possible 4th visit
of 30 minutes. The skin prick test is a safe test and is routinely performed in
the outpatient department clinic. In most cases, the participant will get a
wheal (looks like a mosquito bite). The itching disappears after 15-30 minutes
and the wheal itself after about 2-3 hours. The risk of the blood collection
and intravenous drip during food challenge is a slight pain and the possibility
of a bruise.
The result of a food challenge is an allergic reaction that can range from mild
symptoms (itching in the mouth) to a (rarely) anaphylactic reaction. During
provocation, there are good precautions to minimalize the risk: medications can
be administered immediately by the intravenous drip if needed and there will be
a continuous observation until 2 hours after provocation by experienced nurses
who work daily with food challenges. The whole food challenge is performed
under the supervision of a physician.
Heidelberglaan 100
Utrecht 3508 GA
NL
Heidelberglaan 100
Utrecht 3508 GA
NL
Listed location countries
Age
Inclusion criteria
- age 18 years or older
- suspected history of adverse type I allergic reaction to walnut
Exclusion criteria
- congenital/acquired immune disorder
- lymfoproliferative disease
- use of systemic immune suppressants
- pregnancy
- use of beta blockers
- severe asthma, defined as FEV1 < 70%
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 | NL38180.041.11 |