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 range2 Years – 70 Years

SexALL

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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

What they're measuring

Baseline Immunophenotyping of peanut versus tree nut allergic participants

Timeframe: From enrollment to after 18 months of oral immunotherapy

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

Trial details

NCT IDNCT06554691

SponsorLuxembourg Institute of Health

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2026-12

View on ClinicalTrials.gov More Food Allergy trials