Clinical Trial

Understanding the Immune System's Role in Tree Nut and Peanut Allergies: Key Biomarkers for Diagnosis and Treatment Monitoring and Treatment Targets

Study acronym: Markers4Care
Active, Not Recruiting
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-08-12.
Status change: Recruiting → Active, Not Recruiting 2025-12-01
Trial Details
NCT Number NCT06554691
Lead Sponsor Luxembourg Institute of Health
Collaborators: Centre Hospitalier du Luxembourg
Conditions Food Allergy, Food Allergy in Children, Food Allergy Peanut, Tree Nut Allergies, Allergy;Food, Oral Immunotherapy for Food Allergy
Enrollment 90 participants
Start Date 2023-10-02
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2025-12-02