Food AllergyNCT03680066
Study to Assess Tolerance of Traces in Peanut/Tree Nut Allergic Children.
A study testing Oral food challenge to foods with traces in people with Food Allergy and Peanut Allergy, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Allergy, Peanut Allergy, Tree Nut Allergy
- What is being tested?
- Oral food challenge to foods with traces
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Apr 2018to 28 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Children aged 2-18 years at time of inclusion
- Tree nut or peanut allergy documented by:
- Positive skin prick tests (SPTs) to peanut and/or tree nuts
- Positive specific IgE (sIgE) to peanut and/or tree nuts ( ≥0.35 kU/L)
- A recent (< 1 year) positive food challenge, reacting to the dose of 30 mg of proteins or below.
- Parent/Legal guardian has been informed about the study and has signed Informed Consent Form
Who cannot join
- History of a moderate or severe reaction during a food challenge with a dose of 30 mg of proteins or less.
- Expected non-adherence to the study protocol.
- Severe or uncontrolled asthma.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Pediatric Allergy Unit - University Hospitals of Geneva
Geneva, 1205
About this study
Official title: Assessing Tolerance to "May Contain Traces" Processed Foods in Tree Nuts or Peanut Allergic Children.
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.
Read the detailed description
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:
- 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.
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.
- Conditions
- Food Allergy, Peanut Allergy, Tree Nut Allergy
- Being tested
- Oral food challenge to foods with traces
- Keywords
- Peanut allergy, Tree Nut allergy, Precautionary allergen labeling, May contain traces, Allergen threshold
- Medical subject headings
- Food Hypersensitivity, Peanut Hypersensitivity, Nut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral food challenge to foods with tracesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Foods with traces | Experimental | Oral food challenge with foods with traces Receives: Other: Oral food challenge to foods with traces |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At study entry
Secondary outcomes (4)
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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: At entry and after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Study start1 Apr 2018
- Primary completion28 Nov 2023
- Study completion28 Nov 2023
Why it stopped: recruitment stopped due to low number of subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philippe Eigenmann, University Hospital, Geneva
- Investigators
- Philippe Eigenmann, MD, Principal investigator, University Hospitals of Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03680066
- Sponsor's protocol ID
- CCER 2017-01413
- Status last verified
- Nov 2023
- First submitted
- 25 Jul 2018
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Tolerance to "May Contain Traces" Processed Foods in Tree Nuts or Peanut Allergic Children.
- ClinicalTrials.gov ID
- NCT03680066
- Acronym / sponsor ID
- CCER 2017-01413
- Conditions
- Food Allergy, Peanut Allergy, Tree Nut Allergy
- Keywords
- Peanut allergy, Tree Nut allergy, Precautionary allergen labeling, May contain traces, Allergen threshold
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment stopped due to low number of subjects
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 28 Nov 2023 (actual)
- Study completion
- 28 Nov 2023 (actual)
- First posted
- 21 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- 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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Foods with traces | Experimental | Other: Oral food challenge to foods with tracesOral food challenge with foods with traces |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Children aged 2-18 years at time of inclusion
- Tree nut or peanut allergy documented by:
- Parent/Legal guardian has been informed about the study and has signed Informed Consent Form
Key exclusion criteria (3 listed)
- History of a moderate or severe reaction during a food challenge with a dose of 30 mg of proteins or less.
- Expected non-adherence to the study protocol.
- Severe or uncontrolled asthma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral food challenge to foods with tracesSubjects 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. | Other | Foods with traces |
Primary outcome
Result of the food challenges with foods labelled with "may contain traces" (tolerated or reacted).
Time frame: At study entry
Result of the food challenges with foods labelled with "may contain traces" (tolerated or reacted).
4 secondary outcomes
Tolerance to foods labelled with "may contain traces" eaten normally during a 3 months follow-up.
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.
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.
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.
Time frame: At entry and after 3 months
Results and safety
The study was stopped early (reason given: recruitment stopped due to low number of subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Eigenmann, MD principal investigator
University Hospitals of Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral food challenge to foods with traces in people with Food Allergy and Peanut Allergy, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: recruitment stopped due to low number of subjects). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Result of the food challenges with foods labelled with "may contain traces" (tolerated or reacted). (time frame: At study entry). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.