Food AllergyMarkers4CareNCT06554691
Understanding the Immune System's Role in Tree Nut and Peanut Allergies: Key Biomarkers for Diagnosis and Treatment Monitoring and Treatment Targets
An observational study of Food Allergy and Food Allergy in Children, run by Luxembourg Institute of Health at 2 sites in Luxembourg.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Allergy, Food Allergy in Children, Food Allergy Peanut
- Type of treatment
- Pill or oral medicine
- How many people
- 90 participants
- Where
- 2 sitesLuxembourg
- Study dates
- 2 Oct 2023to Dec 2026
- How long will I take part?
- 18 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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
- Adults
- Male or Female
Show all 9Show fewer
- Sign an Informed Consent
- Tolerates any type of nut
- No known food allergy
Who cannot join
- 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 :
Show all 17Show fewer
- 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
- Pregnancy
- Co-existing chronic medical condition such as cardiovascular disorders
Trial locations and contacts
2 sites in 1 country.
Luxembourg2 sites
Centre Hospitalier de Luxembourg
Luxembourg, 1210
Clinical and Epidemiological Investigation Center, Luxembourg Institute of Health
Luxembourg, 1210
About this study
Official title: Exploring the Immunological Basis in the Evolution of Tree Nut and Peanut Allergy During Treatment Care for Understanding Markers and Treatment Targets
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.
Read more
The main questions the study aims to answer are:
- Identify immune markers that correlate with clinical reactivity
- 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.
Read the detailed description
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:
- For OIT group:
- During the baseline and final OFC , blood samples will be collected at the beginning, during and at the end of the food challenge in three different vials.
- During OIT follow-up, a one-time blood sample will be collected at the end of the build-up phase and after 6 months of maintenance phase in addition to the routine blood collection during these follow-up visits. ii) For avoidance group:
- During the baseline OFC , blood samples will be collected at the beginning, during and at the end of the food challenge.
- During follow-up visits, one-time blood sampling will be taken six monthly i.e. at 6, 12 and 18 months after the baseline OFC. 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.
- Conditions
- Food Allergy, Food Allergy in Children, Food Allergy Peanut, Tree Nut Allergies, Allergy;Food, Oral Immunotherapy for Food Allergy
- Keywords
- food allergy, peanut allergy, tree nut allergy, nut allergy
- Medical subject headings
- Food Hypersensitivity, Peanut Hypersensitivity, Nut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Oral Immunotherapy | Participants in this group undergo oral immunotherapy as part of their routine management of their nut allergies | |
| Avoidance diet | Participants in this group are on strict avoidance diet as part of their nut allergy management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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 outcomes (1)
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
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start2 Oct 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Luxembourg Institute of Health
- Sponsor type
- Other government
- Collaborators
- Centre Hospitalier du Luxembourg
- Responsible party
- Sponsor
- Investigators
- Annette Kuehn, Principal investigator, Luxembourg Institute of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06554691
- Sponsor's protocol ID
- 230043_Markers4Care
- Other IDs
- PRIDE 19/14254520 i2TRON, PRIDE 16749720 NEXTIMMUNE2
- Acronym
- Markers4Care
- Status last verified
- Sep 2025
- First submitted
- 12 Aug 2024
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Luce S, Chinthrajah S, Lyu SC, Nadeau KC, Mascarell L. Th2A and Th17 cell frequencies and regulatory markers as follow-up biomarker candidates for successful multifood oral immunotherapy. Allergy. 2020 Jun;75(6):1513-1516. doi: 10.1111/all.14180. Epub 2020 Jan 31. No abstract available.
PubMed 31930521Bajzik V, DeBerg HA, Garabatos N, Rust BJ, Obrien KK, Nguyen QA, O'Rourke C, Smith A, Walker AH, Quinn C, Gersuk VH, Farrington M, Jeong D, Vickery BP, Adelman DC, Wambre E. Oral desensitization therapy for peanut allergy induces dynamic changes in peanut-specific immune responses. Allergy. 2022 Aug;77(8):2534-2548. doi: 10.1111/all.15276. Epub 2022 Mar 14.
PubMed 35266148Monian B, Tu AA, Ruiter B, Morgan DM, Petrossian PM, Smith NP, Gierahn TM, Ginder JH, Shreffler WG, Love JC. Peanut oral immunotherapy differentially suppresses clonally distinct subsets of T helper cells. J Clin Invest. 2022 Jan 18;132(2):e150634. doi: 10.1172/JCI150634.
PubMed 34813505Santos AF, Du Toit G, O'Rourke C, Becares N, Couto-Francisco N, Radulovic S, Khaleva E, Basting M, Harris KM, Larson D, Sayre P, Plaut M, Roberts G, Bahnson HT, Lack G. Biomarkers of severity and threshold of allergic reactions during oral peanut challenges. J Allergy Clin Immunol. 2020 Aug;146(2):344-355. doi: 10.1016/j.jaci.2020.03.035. Epub 2020 Apr 18.
PubMed 32311390Calise J, DeBerg H, Garabatos N, Khosa S, Bajzik V, Calderon LB, Aldridge K, Rosasco M, Ferslew BC, Zhu T, Smulders R, Wheatley LM, Laidlaw TM, Qin T, Chichili GR, Adelman DC, Farrington M, Robinson D, Jeong D, Jones SM, Sanda S, Larson D, Kwok WW, Baloh C, Nepom GT, Wambre E; IMPACT. Distinct trajectories distinguish antigen-specific T cells in peanut-allergic individuals undergoing oral immunotherapy. J Allergy Clin Immunol. 2023 Jul;152(1):155-166.e9. doi: 10.1016/j.jaci.2023.03.020. Epub 2023 Mar 30.
PubMed 37003475Zhou X, Yu W, Lyu SC, Macaubas C, Bunning B, He Z, Mellins ED, Nadeau KC. A positive feedback loop reinforces the allergic immune response in human peanut allergy. J Exp Med. 2021 Jul 5;218(7):e20201793. doi: 10.1084/jem.20201793. Epub 2021 May 4.
PubMed 33944900Wanniang N, Boehm TM, Codreanu-Morel F, Divaret-Chauveau A, Assugeni I, Hilger C, Kuehn A. Immune signatures predicting the clinical outcome of peanut oral immunotherapy: where we stand. Front Allergy. 2023 Oct 2;4:1270344. doi: 10.3389/falgy.2023.1270344. eCollection 2023.
PubMed 37849958Neeland MR, Andorf S, Manohar M, Dunham D, Lyu SC, Dang TD, Peters RL, Perrett KP, Tang MLK, Saffery R, Koplin JJ, Nadeau KC. Mass cytometry reveals cellular fingerprint associated with IgE+ peanut tolerance and allergy in early life. Nat Commun. 2020 Feb 27;11(1):1091. doi: 10.1038/s41467-020-14919-4.
PubMed 32107388Sampson HA, Gerth van Wijk R, Bindslev-Jensen C, Sicherer S, Teuber SS, Burks AW, Dubois AE, Beyer K, Eigenmann PA, Spergel JM, Werfel T, Chinchilli VM. Standardizing double-blind, placebo-controlled oral food challenges: American Academy of Allergy, Asthma & Immunology-European Academy of Allergy and Clinical Immunology PRACTALL consensus report. J Allergy Clin Immunol. 2012 Dec;130(6):1260-74. doi: 10.1016/j.jaci.2012.10.017. No abstract available.
PubMed 23195525Pajno GB, Fernandez-Rivas M, Arasi S, Roberts G, Akdis CA, Alvaro-Lozano M, Beyer K, Bindslev-Jensen C, Burks W, Ebisawa M, Eigenmann P, Knol E, Nadeau KC, Poulsen LK, van Ree R, Santos AF, du Toit G, Dhami S, Nurmatov U, Boloh Y, Makela M, O'Mahony L, Papadopoulos N, Sackesen C, Agache I, Angier E, Halken S, Jutel M, Lau S, Pfaar O, Ryan D, Sturm G, Varga EM, van Wijk RG, Sheikh A, Muraro A; EAACI Allergen Immunotherapy Guidelines Group. EAACI Guidelines on allergen immunotherapy: IgE-mediated food allergy. Allergy. 2018 Apr;73(4):799-815. doi: 10.1111/all.13319. Epub 2017 Dec 5.
PubMed 29205393Schoos AM, Bullens D, Chawes BL, Costa J, De Vlieger L, DunnGalvin A, Epstein MM, Garssen J, Hilger C, Knipping K, Kuehn A, Mijakoski D, Munblit D, Nekliudov NA, Ozdemir C, Patient K, Peroni D, Stoleski S, Stylianou E, Tukalj M, Verhoeckx K, Zidarn M, van de Veen W. Immunological Outcomes of Allergen-Specific Immunotherapy in Food Allergy. Front Immunol. 2020 Nov 3;11:568598. doi: 10.3389/fimmu.2020.568598. eCollection 2020.
PubMed 33224138Zhang L, Chun Y, Arditi Z, Grishina G, Lo T, Wisotzkey K, Agashe C, Grishin A, Wang J, Sampson HA, Sicherer S, Berin MC, Bunyavanich S. Joint transcriptomic and cytometric study of children with peanut allergy reveals molecular and cellular cross talk in reaction thresholds. J Allergy Clin Immunol. 2024 Jun;153(6):1721-1728. doi: 10.1016/j.jaci.2023.12.028. Epub 2024 Jan 23.
PubMed 38272374Klueber J, Czolk R, Codreanu-Morel F, Montamat G, Revets D, Konstantinou M, Cosma A, Hunewald O, Skov PS, Ammerlaan W, Hilger C, Bindslev-Jensen C, Ollert M, Kuehn A. High-dimensional immune profiles correlate with phenotypes of peanut allergy during food-allergic reactions. Allergy. 2023 Apr;78(4):1020-1035. doi: 10.1111/all.15408. Epub 2022 Jun 24.
PubMed 35700055
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Immunological Basis in the Evolution of Tree Nut and Peanut Allergy During Treatment Care for Understanding Markers and Treatment Targets
- ClinicalTrials.gov ID
- NCT06554691
- Acronym / sponsor ID
- Markers4Care / 230043_Markers4Care
- Conditions
- Food Allergy, Food Allergy in Children, Food Allergy Peanut, Tree Nut Allergies, Allergy;Food, Oral Immunotherapy for Food Allergy
- Keywords
- food allergy, peanut allergy, tree nut allergy, nut allergy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Luxembourg Institute of HealthOther government
- Collaborators
- Centre Hospitalier du Luxembourg
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Identify immune markers that correlate with clinical reactivity
- 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.
Detailed description
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:
- For OIT group:
- During the baseline and final OFC , blood samples will be collected at the beginning, during and at the end of the food challenge in three different vials.
- During OIT follow-up, a one-time blood sample will be collected at the end of the build-up phase and after 6 months of maintenance phase in addition to the routine blood collection during these follow-up visits. ii) For avoidance group:
- During the baseline OFC , blood samples will be collected at the beginning, during and at the end of the food challenge.
- During follow-up visits, one-time blood sampling will be taken six monthly i.e. at 6, 12 and 18 months after the baseline OFC. 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Immunotherapy | – | –Participants in this group undergo oral immunotherapy as part of their routine management of their nut allergies |
| Avoidance diet | – | –Participants in this group are on strict avoidance diet as part of their nut allergy management |
Who may qualify
- Ages
- 2 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (9 listed)
- 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
- Adults
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Baseline Immunophenotyping of peanut versus tree nut allergic participants
Time frame: From enrollment to after 18 months of oral immunotherapy
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.
Immune changes during Oral Food Challenge and Immune changes from baseline to 18 months of Oral Immunotherapy
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
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.
1 secondary outcome
Integration of the immune cell changes observed from the primary outcome with the serological and other immunological parameters
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Background: PubMed 31930521Luce S, Chinthrajah S, Lyu SC, Nadeau KC, Mascarell L. Th2A and Th17 cell frequencies and regulatory markers as follow-up biomarker candidates for successful multifood oral immunotherapy. Allergy. 2020 Jun;75(6):1513-1516. doi: 10.1111/all.14180. Epub 2020 Jan 31. No abstract available.
- Background: PubMed 35266148Bajzik V, DeBerg HA, Garabatos N, Rust BJ, Obrien KK, Nguyen QA, O'Rourke C, Smith A, Walker AH, Quinn C, Gersuk VH, Farrington M, Jeong D, Vickery BP, Adelman DC, Wambre E. Oral desensitization therapy for peanut allergy induces dynamic changes in peanut-specific immune responses. Allergy. 2022 Aug;77(8):2534-2548. doi: 10.1111/all.15276. Epub 2022 Mar 14.
- Background: PubMed 34813505Monian B, Tu AA, Ruiter B, Morgan DM, Petrossian PM, Smith NP, Gierahn TM, Ginder JH, Shreffler WG, Love JC. Peanut oral immunotherapy differentially suppresses clonally distinct subsets of T helper cells. J Clin Invest. 2022 Jan 18;132(2):e150634. doi: 10.1172/JCI150634.
- Background: PubMed 32311390Santos AF, Du Toit G, O'Rourke C, Becares N, Couto-Francisco N, Radulovic S, Khaleva E, Basting M, Harris KM, Larson D, Sayre P, Plaut M, Roberts G, Bahnson HT, Lack G. Biomarkers of severity and threshold of allergic reactions during oral peanut challenges. J Allergy Clin Immunol. 2020 Aug;146(2):344-355. doi: 10.1016/j.jaci.2020.03.035. Epub 2020 Apr 18.
- Background: PubMed 37003475Calise J, DeBerg H, Garabatos N, Khosa S, Bajzik V, Calderon LB, Aldridge K, Rosasco M, Ferslew BC, Zhu T, Smulders R, Wheatley LM, Laidlaw TM, Qin T, Chichili GR, Adelman DC, Farrington M, Robinson D, Jeong D, Jones SM, Sanda S, Larson D, Kwok WW, Baloh C, Nepom GT, Wambre E; IMPACT. Distinct trajectories distinguish antigen-specific T cells in peanut-allergic individuals undergoing oral immunotherapy. J Allergy Clin Immunol. 2023 Jul;152(1):155-166.e9. doi: 10.1016/j.jaci.2023.03.020. Epub 2023 Mar 30.
- Background: PubMed 33944900Zhou X, Yu W, Lyu SC, Macaubas C, Bunning B, He Z, Mellins ED, Nadeau KC. A positive feedback loop reinforces the allergic immune response in human peanut allergy. J Exp Med. 2021 Jul 5;218(7):e20201793. doi: 10.1084/jem.20201793. Epub 2021 May 4.
- Background: PubMed 37849958Wanniang N, Boehm TM, Codreanu-Morel F, Divaret-Chauveau A, Assugeni I, Hilger C, Kuehn A. Immune signatures predicting the clinical outcome of peanut oral immunotherapy: where we stand. Front Allergy. 2023 Oct 2;4:1270344. doi: 10.3389/falgy.2023.1270344. eCollection 2023.
- Background: PubMed 32107388Neeland MR, Andorf S, Manohar M, Dunham D, Lyu SC, Dang TD, Peters RL, Perrett KP, Tang MLK, Saffery R, Koplin JJ, Nadeau KC. Mass cytometry reveals cellular fingerprint associated with IgE+ peanut tolerance and allergy in early life. Nat Commun. 2020 Feb 27;11(1):1091. doi: 10.1038/s41467-020-14919-4.
- Background: PubMed 23195525Sampson HA, Gerth van Wijk R, Bindslev-Jensen C, Sicherer S, Teuber SS, Burks AW, Dubois AE, Beyer K, Eigenmann PA, Spergel JM, Werfel T, Chinchilli VM. Standardizing double-blind, placebo-controlled oral food challenges: American Academy of Allergy, Asthma & Immunology-European Academy of Allergy and Clinical Immunology PRACTALL consensus report. J Allergy Clin Immunol. 2012 Dec;130(6):1260-74. doi: 10.1016/j.jaci.2012.10.017. No abstract available.
- Background: PubMed 29205393Pajno GB, Fernandez-Rivas M, Arasi S, Roberts G, Akdis CA, Alvaro-Lozano M, Beyer K, Bindslev-Jensen C, Burks W, Ebisawa M, Eigenmann P, Knol E, Nadeau KC, Poulsen LK, van Ree R, Santos AF, du Toit G, Dhami S, Nurmatov U, Boloh Y, Makela M, O'Mahony L, Papadopoulos N, Sackesen C, Agache I, Angier E, Halken S, Jutel M, Lau S, Pfaar O, Ryan D, Sturm G, Varga EM, van Wijk RG, Sheikh A, Muraro A; EAACI Allergen Immunotherapy Guidelines Group. EAACI Guidelines on allergen immunotherapy: IgE-mediated food allergy. Allergy. 2018 Apr;73(4):799-815. doi: 10.1111/all.13319. Epub 2017 Dec 5.
- Background: PubMed 33224138Schoos AM, Bullens D, Chawes BL, Costa J, De Vlieger L, DunnGalvin A, Epstein MM, Garssen J, Hilger C, Knipping K, Kuehn A, Mijakoski D, Munblit D, Nekliudov NA, Ozdemir C, Patient K, Peroni D, Stoleski S, Stylianou E, Tukalj M, Verhoeckx K, Zidarn M, van de Veen W. Immunological Outcomes of Allergen-Specific Immunotherapy in Food Allergy. Front Immunol. 2020 Nov 3;11:568598. doi: 10.3389/fimmu.2020.568598. eCollection 2020.
- Background: PubMed 38272374Zhang L, Chun Y, Arditi Z, Grishina G, Lo T, Wisotzkey K, Agashe C, Grishin A, Wang J, Sampson HA, Sicherer S, Berin MC, Bunyavanich S. Joint transcriptomic and cytometric study of children with peanut allergy reveals molecular and cellular cross talk in reaction thresholds. J Allergy Clin Immunol. 2024 Jun;153(6):1721-1728. doi: 10.1016/j.jaci.2023.12.028. Epub 2024 Jan 23.
- Individual participant dataSharing planned: No
Related trials for Food Allergy
RecruitingObservational study
Natural History and Genetics of Food Allergy and Related Conditions
Food Allergy, Loeys-Dietz Syndrome
Not yet recruiting
Performance of the Basophil Activation Test in the Diagnosis of IgE-mediated Cow's Milk Allergy in Infants and Evaluation of Hydrolysate Allergenicity.
Milk Allergy
RecruitingPhase 4
Oral Food Challenge After One to Two Doses of Omalizumab Treatment for Food Allergy
Food Allergy
Active, not recruiting
Slow Multiallergen Oral Immunotherapy in Young Children
Food Allergy, Oral Immunotherapy for Food Allergy
Not yet recruiting
Immunotherapy for Curing Toddlers With Severe Food Allergy - a Paradigm Shift From Passive to Active Treatment With Multi-allergen Oral Immunotherapy
Food Allergy in Children
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annette Kuehn principal investigator
Luxembourg Institute of Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Food Allergy and Food Allergy in Children, run by Luxembourg Institute of Health at 2 sites in Luxembourg.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Luxembourg. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline Immunophenotyping of peanut versus tree nut allergic participants (time frame: From enrollment to after 18 months of oral immunotherapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06554691, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.