The overall aim of this study is to find objective and sensitive markers to predict short term and long term food challenge outcome. Primary Objectives: - Can we predict (severity of) short- and long-term food challenge outcome with clinical and…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Voedselallergie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Differences between children with positive and children with negative
short-term food challenge outcome
- Differences between children with positive and children with negative long
term food challenge outcome
Secondary outcome
Clinical parameters measured during challenge to discriminate between children
with positive and negative short term food challenge outcome
Symptom Scores, VAS-scores, heart rate, saturation, breathing pattern, FEV1,
blood pressure, temperature, VAS-scores, dermographism and eczema scores.
Background summary
At present, the double blind placebo controlled food challenge (DBPCFC)
represents the gold standard for the definitive diagnose of food allergy. The
DBPCFC is terminated and considered positive when objective symptoms occur.
However, there are several pitfalls in performing and interpreting food
challenges. Food challenges are expensive due to the time consuming procedure
and the need of trained staff. Moreover challenges can be dangerous by bearing
the risk of a severe allergic reaction. In children, the portion size and total
volume of the challenge food can be a problem. Furthermore, especially in young
children, symptoms during challenge can be difficult to interpret. Subjective
symptoms (abdominal complaints, oral allergy syndrome, change of behaviour) are
difficult to objectify and without extensive monitoring; less obvious objective
symptoms (as mild bronchoconstriction or change in blood pressure) are easily
missed. As a result false-negative tests do occur and negative challenges are
sometimes followed by an allergic reaction upon the reintroduction of the
allergen. With this study we aim to predict short term and long term food
challenge outcome with regular available patient data and objective clinical
and laboratory measurements before, during and after food challenge. Hereby we
tend to reduce the amount of food challenges by at least 50%.
Study objective
The overall aim of this study is to find objective and sensitive markers to
predict short term and long term food challenge outcome.
Primary Objectives:
- Can we predict (severity of) short- and long-term food challenge outcome with
clinical and laboratory markers measured before food challenge in children with
suspected food allergy?
Secondary Objective:
- Can we identify objective clinical markers measured during food challenge, to
predict short term and long term food challenge outcome?
- What is the incidence and type of (accidental) allergic reactions during
follow up of positive and negative food challenges?
- Can we find predictors for reintroduction problems after negative food
challenge?
Study design
In this observational study we will use regular available clinical data and
food allergy diagnostics to predict (severity of) food challenge outcome (short
term and long term) in children with suspected food allergy for peanut.
Moreover we will measure in vivo clinical paramters during food challenge to
objectify food challenge outcome. For long term food challenge outcome we will
monitor subjects during 12 months after food challenge.
Study burden and risks
We will study children because it is important to diagnose food allergy at a
young age to prevent unnecessary restricted diets further in live. Moreover,
especially in children subjective reactions during challenge occur and subtle
reactions are difficult to objectivity. Therefore especially in children it is
important improve the diagnostics tools to detect food allergy and where
possible, reduce the amount of challenges.
There are no risks associated with participation to this study. There are no
individual patient benefits for the participation of this study. In the future,
the results of this study can lead to an improved diagnostic procedure in
patients with suspected food allergy and prevent children from challenge, more
over this study can lead to ore objective food challenge test outcomes.
Lundlaan 6
Utrecht 3508 AB
NL
Lundlaan 6
Utrecht 3508 AB
NL
Listed location countries
Age
Inclusion criteria
- Child is between 1 * 18 years old
- Suspected food allergy for peanut by:
1) Raised specific IgE for peanut and/ or positive skin prick test for peanut without previous known
ingestion of the allergen, or;
2) Objective immediate type clinical signs or symptoms (within 2 hours) after ingestion of peanut or
repetitive subjective clinical signs or symptoms after ingestion of peanut with or without raised
specific IgE for peanut / positive skin prick test for peanut; or
3) Objective immediate type clinical signs or symptoms (within 2 hours) after the ingestion of an unknown allergen and raised specific IgE for peanut / positive skin prick test for peanut.;- Parents of the children must be able to speak, read and write Dutch language
Exclusion criteria
- Peanut is eaten regularly in a substantial amount without clinical signs or symptoms
- A previous severe life treating reaction to peanut requiring ICU submission.
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 | NL42365.041.12 |