|- candidate number||13222|
|- NTR Number||NTR3572|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||10-aug-2012|
|- Secondary IDs||NL39127.078.12 CCMO|
|- Public Title||Improvement of Diagnostic mEthods for ALlergy assessment. Cashew allergy in children as a showcase (IDEAL study).|
|- Scientific Title||Improvement of Diagnostic mEthods for ALlergy assessment. Cashew allergy in children as a showcase (IDEAL study).|
|- hypothesis||The hypothesis is that an accurate history, conventional markers of sensitization, IgE antibodies in the serum and positive SPT, and more advanced techniques (MRAs and component resolved diagnosis (CRD)) might predict clinical allergy to cashew nuts. Thereby, the aim of this study is to improve diagnostic procedures for food allergies.|
|- Healt Condition(s) or Problem(s) studied||Cashew nut allergy|
|- Inclusion criteria||1. Age: 2-17 year;|
2. Children with a positive skin prick test (HEP > 0.21) and/ or detectible sIgE (>0.35) to cashew nut;
3. History of positive reaction to cashew nut or an unknown reaction (because of never ingested);
4. Written informed consent parents and child (≥ 12 year old).
|- Exclusion criteria||1. History of severe or uncontrolled asthma (investigatorís opinion);|
2. Severe eczema defined as TIS (Three Item Severity) eczema score (> 6);
3. Immunological diseases, cardiovascular diseases or malignity;
4. Severe psychosocial problems;
5. Not able to stop anti-histamine medication for a short period;
6. Use of beta-blockers;
7. The patient is allergic to one or more of the ingredients of the food matrix, unless a suitable substitute for the ingredient in question can be found;
8. Unable to speak and understand the Dutch language properly;
9. Not willing to comply with the study procedures.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mei-2012|
|- planned closingdate||1-mei-2016|
|- Target number of participants||200|
|- Interventions||1. Double-blind randomized food challenge;|
2. Extra skin prick test;
3. Extra blood sample (12 ml);
4. Completion of questionnaires.
|- Primary outcome||Results mediator release assays in comparison with the existing tests.|
|- Secondary outcome||1. Adverse events;|
2. Prevalence of cashew nut allergy.
|- Timepoints||Week 8.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. N.W. Jong, de|
|- CONTACT for SCIENTIFIC QUERIES||Dr. N.W. Jong, de|
|- Sponsor/Initiator ||Erasmus Medical Center, Rotterdam|
(Source(s) of Monetary or Material Support)
|Technologiestichting STW (Stichting Technische Wetenschappen)|
|- Brief summary||There is an urgent need for improvement of the diagnostic tools foorfood allergy. Current tests jeopardize proper diagnosis due to poor sensitivity and false-positive and false-negative results. The current Standard is the double blind, placebo controlled food chanllenge test. This test is expensive. time consuming and includes the risk of allergie reactions. In addition this test is time consuming and can therefore only be performed in approx. 10% of patients. This means that in 90% of patients incomplete diagnostics are performed. This group is gets dietary advice, while it is uncertain whether they really need this. Mediator Release Assays (MRA) are promising tests for superior results in comparision to the current diagnostic tests, because of a superior relationship with the in-vivo situation. MRAs will result in a more relevant diagnosis, less burdenful test protocols for patients and a significant reduction of costs of food challenges. The prevalence of allergy to cashew in children is incresing considerably. The prevalence is unknown and to date no studies addressing the best diagnostic tools have been performed. This study will provide knowledge about the severity and prevalence of this type of allergy and it is expected thatthe newtest method will make the food challenge test redundant.
Because the food challenge test is only performed in 10% of regular patients, this test is seen as a study related test in this study and not as being part of regular diagnostics.
Therapeutic non-drug intervention study.
Therapeutic, because the patiŽnt directly benefits forthe improved diagnostic actions. The diagnosis is more solid and
therefore the dietary councelling can be better targetted.
Plus for study purposes:
1. Double blind randomized food challenge test;
2. 6 skin prick tests;
3. Blood draw (12 ml) for Mediator Release Assays
Duration approx.2 months per patient.
Children 2 to17 (inclusive) years with suspected allergy to cashew nuts.
Written IC of parents (guardian) and -in case child is 12 years of age or above- also of child.
|- Main changes (audit trail)|
|- RECORD||10-aug-2012 - 12-sep-2012|