An observational study in Food Allergy, Food Allergy in Children and Food Allergy Peanut, sponsored by Luxembourg Institute of Health. Active, not recruiting at 2 sites in Luxembourg. Open to participants aged 2 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-02.
Sponsored by Luxembourg Institute of Health · Observational
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:
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.
Background: The prevalence of peanut together with tree nut allergies have increase over the years and accounts for most of the life-threatening reactions even to minute doses of the allergen. Consequently, peanut and tree-nut allergies cause significant physical and mental burden to patients and their caretakers due to anxiety and fear of anaphylaxis from accidental exposures, stress from following a strict elimination diet, lack of proactive management plan and due to the low probability of natural recovery of such allergies. For decades, the management relied on a strict avoidance of the culprit foods. Oral immune therapy (OIT) is a ground breaking alternative modality to strict avoidance diets. OIT consist of gradual introduction of low doses of the implicated food allergen with the aim to modulate the patient's immune response and help build immunological and clinical tolerance. Though OIT has its strong advantages, the clinical outcome is variable among the patients. Therefore, there is a clear need for reliable ex-vivo biomarkers that are reflective of the clinical progression and therapy outcome that could aid with a more accurate patient stratification for personalized treatment approaches in the future.
Aims: This project aims at measuring immune targets, antibodies, immune cells and immune mediators, in patients' blood during oral food challenges (OFCs) and during the course of standard-of-care oral immunotherapy to identify new immune markers correlating to with the clinical outcome of the treatment. The identification of immune modifications during OIT will allow us to endotype patients and possibly aid in unraveling markers of food challenges and therapy progression as well as OIT outcome.
Luxembourg partners: The Luxembourg Institute of Health (LIH), Department of Infection and Immunity (DII; head Prof. M. Ollert) has the scientific project lead (Principal Investigator Dr. A. Kuehn). Main clinical partners are Dr. F. Codreanu-Morel and Dr. V. Petit-Cordebar from the National Unit of Immunology-Allergology, Centre Hospitalier (CHL), Luxembourg. Medical Principal Investigator for healthy controls is Dr. Alessia Pochesci, MD, Clinical and Epidemiological Investigation Center (CIEC), Luxembourg Institute of Health (LIH), Luxembourg. The Integrated Biobank of Luxembourg (IBBL) will prepare and store a subset of clinical samples until use. Other biological samples are prepared and stored at DII, LIH. Clinical samples (blood, sera, plasma,stool) will be analyzed at DII, LIH.
Project implementation: The clinicians at CHL will perform detailed clinical examinations of participants including skin prick test (SPT), serological analysis for specific IgE and food challenges to the implicated food allergen as per their routine clinical practice at the National Unit of Immunology-Allergology (CHL). Based on the European Academy of Allergy and Clinical Immunology (EAACI) guidelines and procedures established at CHL, all peanut- and tree-nut-allergic participants eligible for the study will undergo a baseline OFC. OFC is adapted from PRACTALL protocol and allergen doses are adjusted according to the clinical reactivity of the patient.
For participants eligible for immunotherapy (N= 30 Peanut-OIT and N=30 Tree nut-OIT), the OIT is based on the established protocol at the clinic and adapted from the current literature. Briefly, participant ingest incremental doses of the allergen (peanut/tree nut) at home until they reach a maintenance dose of 300 mg nut-protein in approximately 26 weeks (6 months). This initial phase of OIT is termed as the build-up phase. This is then followed by continued daily intake of this maintenance dose. After a minimum of 12 months of the maintenance phase of OIT, participants undergo another final OFC at the hospital to assess for desensitization to peanut or tree nut. Participants follow up at the hospital every 6 months i.e at end of the build-up phase, after 6 months and after 12 months of daily intake of maintenance dose.
Participants who are not eligible for OIT (N=30 peanut and tree-nut allergic) and who are on avoidance diet, are also followed up every 6 months for 18 months. However, final OFC will not be done for these participants.
The data collection of the study participants is carried out by the medical lead.
In addition, healthy adults (N=20) tolerating any type of nut and without any known food allergies will be recruited as controls. Dr. Alessia Pochesci, CIEC, LIH is responsible for the data collection from these healthy participants.
Blood sample collection:
i) For OIT group:
ii) For avoidance group:
iii) Healthy Adult participants: A one-time blood sampling will be done.
Stool sample collection:
Stool sample will be collected from nut-allergic participants at baseline and after the completion of a minimum of 18 months of the study duration using commercial at-home stool sampling kits. Participants receive a collection kit, containing special sampling tubes, accessories and instructions.
Collected clinical samples will be pseudonymized at the clinical centers. A synonym list containing the information on the identify of the participants recruited and their corresponding pseudonym, will be available at the clinical center only (medical investigators). Personal data is protected under the regulation (EU) 2016/679 of 27 April 2016 on the protection of individuals with regard to the processing of personal data (GDPR) and the law of 1 August 2018 on the organization of the National Data Protection Commission and the General Data Protection Act.
376 studies on the registry are indexed under Food Hypersensitivity; 90 are open to participants now.
This study's planned enrollment of 90 is below the median of 151 across 120 observational studies indexed under Food Hypersensitivity.
Browse Food Hypersensitivity studies →Luxembourg Institute of Health is the lead sponsor of 28 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
For peanut and tree nut-allergic cohort, participants are selected from the Immnulogy and Allergology Deparment at the Centre Hospitalier de Luxembourg.
For the healthy adults cohort, participants are recruited from the Luxembourg population.
For Peanut and Tree nut Allergic participants
Inclusion criteria:
Exclusion criteria:
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 :
For Healthy Controls
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this group undergo oral immunotherapy as part of their routine management of their nut allergies
Participants in this group are on strict avoidance diet as part of their nut allergy management
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.
Time frame: 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.
Time frame: 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
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
Time frame: 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)
Plan to share: No
Started Oct 2023 (actual). Primary completion is estimated for Dec 2026, 38 months after the start.
Of 42 non-industry observational studies under Food Hypersensitivity, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 250. This study's planned 38 months is close to that.
Counting every sponsor, half of 43 studies reached it within 42 months; a quarter within 19 and three quarters within 250.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Luxembourg Institute of Health