Understanding the Immune System's Role in Tree Nut and Peanut Allergies: Key Biomarkers for Diagnosis and Treatment Monitoring and Treatment Targets
NCT Number: NCT06554691
Acronym: Markers4Care
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Food Allergy|Food Allergy in Children|Food Allergy Peanut|Tree Nut Allergies|Allergy;Food|Oral Immunotherapy for Food Allergy
Sponsor: Luxembourg Institute of Health
Collaborators: Centre Hospitalier du Luxembourg
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-10-02
Completion Date: 2026-12
Locations: Centre Hospitalier de Luxembourg, Luxembourg, 1210, Luxembourg|Clinical and Epidemiological Investigation Center, Luxembourg Institute of Health, Luxembourg, 1210, Luxembourg

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.

Primary Outcome Measures: Baseline Immunophenotyping of peanut versus tree nut allergic participants, To identify the baseline immuonophenotypes using mass cytometry/flow cytometry for peanut versus tree nut-allergic participants and to correlate these findings with the oral food challenge and oral immunotherapy outcome., 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, To investigate and map immune changes reflective of inflammation and cell migration during oral food challenge (OFC) and oral immunotherapy (OIT) in children with nut allergy. We will compare the immune profiles from OFC samples before commencing OIT vs OFC after 18 months of OIT. The immnue changes will also be compared to those nut-allergic participants on avoidance diet., 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
Secondary Outcome Measures: Integration of the immune cell changes observed from the primary outcome with the serological and other immunological parameters, Serological parameters such as specific IgE and immune mediators such as cytokines measured at baseline and follow up visits will be correlated with the immune cell changes observed from the primary outcome, From enrollment to the end of 18 months of immunotherapy (for oral immunotherapy group) and to the end of 18 months follow up (for the avoidance group)