What is the clinical- and cost-effectiveness of early low-dose oral immunotherapy aimed at long-term tolerance induction in children under the age of 30 months with an established food allergy compared to routine care?What is the effect of early low…
ID
Source
Brief title
Condition
- Allergic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Sustained unresponsiveness, defined as passing an exit oral food challenge at 4
weeks after discontinuation of the 12 months oral immunotherapy, and
uncomplicated consumption of a full dose of the specific food at home, after 6
months unrestricted introduction of the specific food into the diet.
Secondary outcome
Quality of life, costs/impact of food allergy and treatment, immunological
parameters (blood tests), adherence to treatment.
Background summary
Recent studies suggest that oral immunotherapy is associated with long-term
tolerance development in food allergic children, but only when started early in
life. Currently, no randomized controlled trials are performed for different
kinds of food allergies in these young children.
Hypothesis: Early low-dose oral immunotherapy in young children with an
established food allergy will induce long-term tolerance within one year in at
least 50% more children compared to the percentage of children who achieve
spontaneous tolerance in the routine care group (strict avoidance of the
allergen).
Study objective
What is the clinical- and cost-effectiveness of early low-dose oral
immunotherapy aimed at long-term tolerance induction in children under the age
of 30 months with an established food allergy compared to routine care?
What is the effect of early low-dose oral immunotherapy in children under the
age of 30 months with an established food allergy on (allergy specific) quality
of life of parents and children compared to routine care?
Study design
Randomized controlled superiority trial
Intervention
1-year low-dose oral immunotherapy (daily 300 mg allergenic protein) compared
to strict avoidance in the control group.
Study burden and risks
Burden: in all children participating in the study, oral food challenges are
performed, and two blood samples are obtained (both will completely or
partially be part of routine diagnostic allergy care). Parents have to fill in
4 questionnaires each 6 months. Children whose allergy is assigned to the
intervention group, have to visit the hospital for an additional 1 to 6 times
during the build-up phase of the treatment and an additional blood sample is
obtained after 6 months of therapy. Parents have to take care of daily
ingestion of the allergenic food by their child at home.
Risks: the main risk of oral immunotherapy is the occurrence of allergic
side-effects. Because a food allergy is definition characterized by an allergic
reaction in case of an accidental ingestion, parents have to be prepared for
the risk of allergic reactions already. Inducing long-term tolerance, the main
goal of this treatment, would prevent a life-long risk of allergic reactions
caused by accidental ingestions.
Group relatedness: current scientific knowledge suggests that only in
food-allergic infants oral immunotherapy may be associated with long-term
tolerance in contradiction with school-aged children.
Nico Bolkensteinlaan 75
Deventer 7416 SE
NL
Nico Bolkensteinlaan 75
Deventer 7416 SE
NL
Listed location countries
Age
Inclusion criteria
- 9 to 30 months of age at inclusion.
- an IgE-mediated food allergy to peanut, cashew, hazelnut, walnut, cow*s milk
and/or hen*s egg as proven by sensitization to the specific allergen (sIgE >
0.35kU/l) and a positive oral food challenge.
- The fore-mentioned allergens are introduced into the diet of the child (the
child is tolerant for the specific allergen(s)), or the child is diagnosed with
a food allergy for the specific allergen(s).
- Informed consent is given by parent(s) or guardian(s).
Exclusion criteria
- (suspected) eosinophilic oesophagitis
- uncontrolled asthma/ viral wheeze.
- the inability of parents to follow instructions, recognize allergic reactions
or administer emergency medication.
- participation in any other intervention study at the time of the OIT study,
with the exception of studies on guided early introduction of highly allergenic
foods.
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 | NL81774.075.22 |