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

NCT06554691 | Active Not Recruiting

• 3 other identifiers: 230043_Markers4CarePRIDE 19/14254520 i2TRONPRIDE 16749720 NEXTIMMUNE2
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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. 1.Identify immune markers that correlate with clinical reactivity
2. 2.Identify immune changes and markers that correlate with immunotherapy outcome

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Integration of the immune cell changes observed from the primary outcome with the serological and other immunological parameters

  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)

Study Arms (2)

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

Eligibility Criteria

• Age: 2 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Luxembourg Institute of Health: lead
• Centre Hospitalier du Luxembourg: collaborator

Study Sites (2)

Centre Hospitalier de Luxembourg

Luxembourg, 1210, Luxembourg

Location

Clinical and Epidemiological Investigation Center, Luxembourg Institute of Health

Luxembourg, 1210, Luxembourg

Location

Related Publications (13)

• 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.

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• Bajzik 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.

  PMID: 35266148 BACKGROUND

• Monian 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.

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• Santos 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.

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• Calise 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.

  PMID: 37003475 BACKGROUND

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  PMID: 33944900 BACKGROUND

• Wanniang 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.

  PMID: 37849958 BACKGROUND

• Neeland 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.

  PMID: 32107388 BACKGROUND

• Sampson 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.

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• Schoos 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.

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Biological samples: Whole blood, sera, plasma and stool samples

MeSH Terms

Conditions

Food Hypersensitivity; Peanut Hypersensitivity; Nut Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Nut and Peanut Hypersensitivity

Study Officials

• Annette Kuehn

  Luxembourg Institute of Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Months
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 15, 2024
• Study Start: October 2, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

LU (2)