Primary: Is OIT with standard food products safe to perform in children aged 9 to 24 months with a proven food allergy for hen's egg, peanut, cow's milk, cashewnut, hazelnut, walnut and/or one of the more rare allergens (as soy, pits and…
ID
Source
Brief title
Condition
- Allergic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety based on the number of anaphylactic reactions that occur within 2 hours
after administration of the food product. Feasibility as assessed by both
parents and doctors. Effectiveness measured as the number of children with
long-term tolerance (SU): a negative provocation test 4 weeks after the
discontinuation of the OIT and a problem-free introduction of the food allergen
in the diet, and the number of children with remission: a negative food
provocation at least 2 years after cessation of OIT, with strict avoidance of
the specific food allergen in in the 12 weeks preceding the provocation test.
Secondary outcome
• Number of children with sustained unresponsiveness: a negative food challenge
4 weeks after discontinuation of OIT.
• Number of children with a problem-free introduction of the food allergen in
the diet 6 months after discontinuation of the OIT.
• Number of children with food allergy remission: a negative food provocation
at least 2 years after cessation of OIT, with strict avoidance of the specific
food allergen in the 12 weeks preceding the food provocation
Background summary
In the Netherlands, a few thousand babies develop a food allergy every year
that often will lead to lifelong restrictions. Oral immunotherapy (OIT) does
not lead to long-term tolerance (sustained unresponsiveness, SU) in older
children and adults and has many side effects. Immunotherapy at a young age has
hardly been studied, but there are good indications that this therapy can lead
to longterm tolerance. By using a lower dose of the food, the number of side
effects is probably limited. Little is known about the further practical
feasibility of this therapy in babies and infants.
Study objective
Primary: Is OIT with standard food products safe to perform in children aged 9
to 24 months with a proven food allergy for hen's egg, peanut, cow's milk,
cashewnut, hazelnut, walnut and/or one of the more rare allergens (as soy, pits
and seeds (sesame seed, pine nut and wheat)? And what is the feasibility of OIT
with a low daily dose of a standard food product in these children?
Secondary: Can OIT induce long-term tolerance (SU) in children with a proven
food allergy in the age of 9 to 24 months (compared to a control group)? And
does tolerance persist in the years following therapy?
Study design
An explorative prospective intervention study combined with a control group to
compare the induction of spontaneous tolerance with the induction of tolerance
by OIT.
Intervention
Children who are enrolled in the ORKA study start with the OIT (daily intake of
a small amount of food for which the patient is allergic) within about 2 weeks
after the provocation test. After the maintenance dose has been reached, this
will be continued for 12 months. Children come to the hospital after 6 months
for an extra check. A provocation takes place 4 weeks after the discontinuation
of the OIT. If this provocation test is negative then a follow-up provocation
test takes place 2 years after discontinuation of OIT after 12 weeks of strict
avoidance of the specific allergen
Study burden and risks
In every child with a food allergy, different tests and / or a food provocation
takes place. The extra burden of this study is: a maximum of 3 blood tests, 2
visits to the policlinic and 2-15 visits to the clinic for provocation or
increasing the dose. Parents will complete questionnaires and track the daily
administration of the food product in an app.
Patients have an extra risk of an allergic reaction, which is usually mild in
nature, but a serious allergic reaction with, for example, bronchoconstriction
is not excluded.
The advantage of participating in the study is the possibility of a definitive
cure for an otherwise lifelong existing food allergy. Parents often find this
possibility more important than the burden of hospital visits, extra blood
collection and the risk of allergic reactions. In addition to the individual
benefit of participating in the study, the study contributes to the development
of a treatment perspective for other children with a food allergy.
Nico Bolkensteinlaan 75
Deventer 7416 SE
NL
Nico Bolkensteinlaan 75
Deventer 7416 SE
NL
Listed location countries
Age
Inclusion criteria
• Children with an age of 9 to 24 months.
• A proven food allergy (positive provocation and sensitization
demonstrated by a skin prick test> 3mm and / or sIgE> 0.35kU / L) for chicken
egg, peanut, cow's milk, cashewnut, hazelnut, walnut and/or one of the more
rare allergens (as soja, pits and seeds (sesameseed and pine nut) and wheat).
• Assessment of the presence of other food allergies (standard care) by
introduction in the diet and / or the determination of sensitization. From the
mentioned allergens, introduction into the diet or the diagnosis food allergy
has been made.
• Written permission (signed informed consent form) from both parents /
guardian for participation in the study.
Exclusion criteria
• Uncontrolled toddler asthma and / or frequent exacerbations (viral
wheezing) defined as toddlers who have been admitted to hospital > 1x in the
past six months because of these complaints.
• Uncontrolled eczema.
• Severe gastrointestinal complaints such as gastroesophageal reflux
disease, where an underlying disease such as eosinophilic esophagitis (EoE)
cannot be excluded.
• Active EoE.
• Mastocytosis (also cutaneous).
• Psycho-social problems in the family that may be a barrier to a good
daily performance of long-term therapy.
• Inability of parents to follow instructions, to recognize allergic
reactions or to administer emergency medication.
• Participation in any other intervention study at the time of the ORKA
study, with the exception of studies on guided early introduction of
high-allergenic nutrition.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL67711.075.18 |