The aim of this study is to compare results of sensitization measurements (positive or negative) in skin test and blood test, with new nutritional proteins in food-allergic patients.
ID
Source
Brief title
Condition
- Allergic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Positive sensitization in skin test [>3 mm ø] and in blood (positive IL-13
release) with novel food proteins
Secondary outcome
nvt
Background summary
Sustainability considerations require the replacement of animal proteins by
plant- or microbe-based alternatives, and stimulation of the valorisation of
waste streams from existing processes. There is a fast-growing demand for the
production of these (vegetable) proteins that, before they can be used
commercially, must be tested for safety before consumption. One of the most
important safety aspects is screening new products for their potential to cause
an allergic reaction. An allergic reaction only occurs if the person is
sensitized. This involves the presence of specific immunoglobulin E (sIgE)
against the relevant allergen (sensitization), demonstrated in the skin prick
test (SPT) or in the blood. Without the presence of specific IgE, the patient
cannot react allergically to a protein. No suitable animal models are available
to predict sensitization in humans. The aim of this study is to compare results
of sensitization measurements (positive or negative) in skin test and blood
test, for new nutritional proteins in food-allergic patients.
Study objective
The aim of this study is to compare results of sensitization measurements
(positive or negative) in skin test and blood test, with new nutritional
proteins in food-allergic patients.
Study design
Observational study with interventions
Study burden and risks
During the visit, an SPT (maximaal N= 9) will be performed with extracts of
novel foods, phylogenetically/biologically related to the proteins to which the
patient is proven to be allergic. These novel foods are supplied by industry
and the patient is tested with a maximum of 6 novel food proteins (2 proteins
per industry, maximum 3 industries) per patient. This is to keep the burden on
the patient as low as possible. Differences between the 2 samples per industry,
lies in the pre-processing such as heated or unheated, frozen or freeze-dried,
protein isolate or whole product. The biological background remains unchanged.
For the skin prick test (SPT), a choice is made per individual patient from the
proteins of the seven industries, with a maximum of 3 industries.
Only proteins from Industries are chosen that are phylogenetically/biologically
related to proteins to which the patient is food allergic. Proteins from other
industries that are phylogenetically/biologically unrelated to the proteins to
which the patient is food allergic are not tested in the patient.
Example: A patient is allergic/sensitized to wheat. There is 1 company that
supplies a new wheat-related protein: Cargill R&D Center Europe. The patient is
only tested with 2 new comparable proteins from this company in addition to the
usual 3 controls. (total 5) Another patient is allergic/sensitized to cow's
milk. There are three companies, each with 2 new cow's milk-related proteins.
3x2 new proteins are tested. Proteins from other industries are not tested in
the.
A red itchy bump may develop 15 minutes after the SPT, which will disappear on
its own. Reactions elsewhere in the body do not occur with an SPT, not even
with new food allergens. The extracts are made in-house in a 10% solution in
PBS as stated in the current protocol in KIS. 3 tubes of blood are taken. A
bruise may develop after the blood test, which will disappear on its own. The
visit will take 1 hour.
dr molewaterplein 40
Rotterdam 3015 CA
NL
dr molewaterplein 40
Rotterdam 3015 CA
NL
Listed location countries
Age
Inclusion criteria
Signed informed consent
18 years of age or older, mentally competent
Patients diagnosed with a food allergy
Sensitization (Positive skin test [>3 mm ø] or positive specific serum IgE [>
0.35 kU/L]) to at least 1 protein phylogenetically/biologically related to a
new protein supplied by the industry.
Exclusion criteria
Patient does not have a food allergy
Antihistamines used in the last 72 hours before the skin prick test
Unable to stop beta-blockers
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 | NL83872.078.23 |