An interventional study of Oral food challenge to foods with traces in Food Allergy, Peanut Allergy and Tree Nut Allergy, sponsored by University Hospital, Geneva. Terminated at 1 site in Switzerland. Open to participants aged 2 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-05.
Sponsored by University Hospital, Geneva · Not applicable, Interventional, and Other
This protocol will help better define whether patients with peanut and/or tree nut food allergy can tolerate traces in products with precautionary allergen labelling.
Visit 1 (V1): During this visit at the Pediatric Research Platform at the Children's Hospital, subjects will undergo an open food challenge to 3 processed foods labeled with "may contain traces" by following safety and accuracy guidelines for food challenges (7). The following foods (similar for all patients) will be given in one dose in the size of a regular serving:
Each meal will be administered with a 1 hour observation period in between and at the end.
If the patient does not react to any of the foods or has only oral itching (mild symptoms), he/she will be instructed to stop the ban on "may contain" foods and eat them regularly. If the patient has more than mild symptoms, the study will be stopped and the patient will be banned from eating foods with traces. The study subjects with a negative challenge and instructed to eat foods with the "may contain" label will be provided emergency medications and instruction on when and how to use them according to current guidelines (8).
An age appropriate quality of life questionnaire will be filled out by the parents/patient during the visit.
For the following 3 months after "may contain food" challenges, the patients will be invited to eat on a regular basis any foods labeled as "may contain" tree nuts and/or peanuts and record the consumption on a diary. Such foods will only be eaten in presence of a family member instructed for the measures to be taken in case of a reaction. They will record any history of reaction and contact the study team. The brand name of the food, and if available the batch will be recorded. The participants will store the study food and its packaging safely in a box and bring it along at V2 for allergen content analysis.
If a reaction occurs, the food will be analyzed for allergen content by immunoaffinity capillary elecrophoresis-matrix assisted laser desorption/ionization mass spectrometry, as well as a simplified version of this technique, the immunomagnetic separation -matrix-assisted laser desorption/ionization mass spectrometry.
Visit 2 (V2): During this visit, the parents/patients will report on the brand, the frequency and the amount of "may contain" foods eaten since V1.
The quality of life questionnaire will be filled out again by the parents/patient.
376 studies on the registry are indexed under Food Hypersensitivity; 90 are open to participants now.
This study's enrollment of 15 is below the median of 60 across 246 interventional studies indexed under Food Hypersensitivity.
Browse Food Hypersensitivity studies →University Hospital, Geneva is the lead sponsor of 379 studies on the registry; 70 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Tree nut or peanut allergy documented by:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Oral food challenge with foods with traces
Other: Oral food challenge to foods with traces
Subjects will undergo an open food challenge to 3 processed foods labeled with "may contain traces". The following foods (similar for all patients) will be given in one dose in the size of a regular serving: * cookies, max 30 g; * chocolate, max 30 g; * breakfast cereals, max 50 g. Each meal will be administered with a 1 hour observation period in between and at the end.
Result of the food challenges with foods labelled with "may contain traces" (tolerated or reacted).
Result of the food challenges with foods labelled with "may contain traces" (tolerated or reacted).
Time frame: At study entry
Tolerance to foods labelled with "may contain traces" eaten normally during a 3 months follow-up.
Tolerance to foods labelled with "may contain traces" eaten normally during a 3 months follow-up (reactions / no reactions to these foods).
Time frame: During 3 months follow-up
Frequency of reactions to foods labelled with "may contain traces" eaten normally during a 3 months follow-up.
Frequency of reactions to foods labelled with "may contain traces" eaten normally during a 3 months follow-up (number of reactions).
Time frame: During 3 months follow-up
Severity of reactions to foods labelled with "may contain traces" eaten normally during a 3 months follow-up.
Severity of reactions to foods labelled with "may contain traces" eaten normally during a 3 months follow-up (severity of reactions by reaction type).
Time frame: During 3 months follow-up
Changes of quality of life after 3 months without restriction of foods labelled with "may contain traces", compared to baseline when restricting.
Changes of quality of life measured with the age-appropriate "Food allergy quality of life questionnaire (0-12 years \[parents\], 7-12 years \[patients\], or 13-17 years \[patients\]. Results (on a continuous numerical ranking from 1 to 6 for each item) after 3 months without restriction of foods labelled with "may contain traces", are compared to baseline when restricting.
Time frame: At entry and after 3 months
Plan to share: No
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This study is terminated, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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