Understanding the Immune System's Role in Tree Nut and Peanut Allergies: Key Biomarkers for Diagn… (NCT06554691) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Understanding the Immune System's Role in Tree Nut and Peanut Allergies: Key Biomarkers for Diagnosis and Treatment Monitoring and Treatment Targets
Luxembourg90 participantsStarted 2023-10-02
Plain-language summary
Peanut and tree nuts belong to the main elicitors of pediatric food allergy and are the main cause of near fatal reactions in children requiring emergency management. Oral immunotherapy has emerged as an alternative treatment option for the management of food allergies, to enhance patients' safety and quality of life. Monitoring if the therapy is working relies on oral food challenges during the course of treatment. There is a clear need for reliable biomarkers that are reflective of the clinical progression during oral food challenges and during immunotherapy that would help with patient stratification and possibly for personalized treatment approaches in the future
The aim of this study is to measure immune parameters in the blood of nut-allergic participants during oral food challenges and during the course of oral immunotherapy.
The main questions the study aims to answer are:
1. Identify immune markers that correlate with clinical reactivity
2. Identify immune changes and markers that correlate with immunotherapy outcome
Researchers will compare these immune parameters between nut-allergic participants on oral immunotherapy and with nut-allergic participants on avoidance diet. Additionally, we will also compare the immune parameters of these nut-allergic participants with those healthy adults.
Who can participate
Age range
2 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
For Peanut and Tree nut Allergic participants
Inclusion criteria:
* More than 2 years
* Male or Female
* Allergic to peanut (assessed by anamnesis, skin reactivity testing, sera testing for specific IgE)
* Sign an Informed Consent
Exclusion criteria:
* Pregnancy
* Less than 2 years of age
* Co-existing chronic medical condition such as cardiovascular disorders
* Peanut or tree nut-allergic patients/families who are unwilling to undergo oral food challenges
The eligible participants will be assigned to the oral immunotherapy (OIT) group but if they are not eligible for OIT based on either on the reasons mentioned below, they will be assigned to the avoidance group.
Reasons for ineligibility of OIT :
* risk of poor compliance with immunotherapy
* lack of understanding of the OIT protocol
* uncontrolled asthma
* incompatibility with lifestyle (regular intense physical activities, multiple vacations)
* unwilling to undergo OIT
* long-term or frequent use of non-steroidal anti-inflammatory drugs
* multiple nut allergy with no direct clinical benefit of OIT to one nut
* co-existing comorbidities such as active systemic autoimmune diseases, active malignancy, eosinophilic esophagitis.
For Healthy Controls
Inclusion Criteria:
* Adults
* Male or Female
* Sign an Informed Consent
* Tolerates any type of nut
* No known food allergy
Exclusion Criteria:
* Pregnancy
* Co-existing chronic medical condition such as cardiovascular disorders
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Baseline Immunophenotyping of peanut versus tree nut allergic participants
Timeframe: From enrollment to after 18 months of oral immunotherapy
2
Immune changes during Oral Food Challenge and Immune changes from baseline to 18 months of Oral Immunotherapy
Timeframe: From enrollment to after 18 months of immunotherapy (for oral immunotherapy group) and from enrollment to the end of 18 months follow up for avoidance diet group