Food AllergiesNCT07764159
Multi-Food Oral Immunotherapy for Peanut and Tree Nuts
A study testing Multi-Food Oral Immunotherapy (Multi-OIT) with Peanut and Tree Nuts Proteins in people with Food Allergies and Food Allergy in Children, run by Medical University of Warsaw at 4 sites in Poland.
Trial summary
This study aims to evaluate the efficacy and safety of multi-food oral immunotherapy (multi-OIT) using peanut and tree nuts proteins in children with confirmed food allergy to at least two allergens. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Food Allergies, Food Allergy in Children, Peanut Allergies
- What is being tested?
- Multi-Food Oral Immunotherapy (Multi-OIT) with Peanut and Tree Nuts Proteins
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 4 sitesPoland
- Study dates
- Sep 2026to Dec 2031
- Phase
- Interventional
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 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 1-12 years;
- Confirmed allergy to at least two allergens included in the protocol, i.e., peanut and/or tree nuts: cashew, walnut, hazelnut, and almond;
- Positive skin prick test (SPT) (wheal diameter ≥ 3 mm) and/or specific IgE (sIgE) level > 0.35 kUA/L for at least two of the analyzed allergens;
- Positive OFC-1 (oral food challenge) of grade I-IV according to the WAO classification for at least two allergens, with a positive reaction occurring after administration of a dose ≥ 3 mg and ≤ 3000 mg of allergen protein;
- Participants may be enrolled based on the abbreviated procedure as outlined in the study description;
- Written informed consent obtained from a legal guardian, and, where applicable, assent from the child in accordance with their age and level of maturity;
- Good prognosis for compliance and cooperation of the patient and their caregivers.
Who cannot join
- Allergic reaction at the lowest challenge dose of 1 mg of allergen protein for any allergen, or no allergic reaction after administration of the maximum dose of 3000 mg of allergen protein for at least four of the analyzed allergens;
- History of anaphylaxis with a grade V reaction according to the WAO classification, either during an oral food challenge or in the patient's medical history;
- Severe asthma;
- Poorly controlled asthma according to GINA 2025 (lack of symptom control and/or ≥2 exacerbations requiring systemic glucocorticoids or ≥1 exacerbation requiring hospitalization within the last 12 months), or in children able to perform spirometry: FEV1 < -1.64 Z-score and/or FEV1/FVC < -1.64 Z-score;
- Eosinophilic gastrointestinal disease;
- Other chronic diseases requiring ongoing treatment which, in the investigator's opinion, may increase the risk associated with study participation or interfere with the interpretation of results, including severe cardiac disease, epilepsy, metabolic disorders, or diabetes;
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- Previous immunotherapy with food allergens;
- Concurrent immunotherapy with aeroallergens;
- Treatment with biologic agents, beta-blockers, ACE inhibitors, or calcium channel blockers;
- Oral corticosteroid therapy meeting any of the following criteria: daily treatment for >1 month within the last 12 months; at least two courses lasting ≥7 days within the last 12 months; one course lasting ≥7 days within the last 3 months;
- Lack of consent to participate in the study or insufficient cooperation of the patient and/or caregivers. In such cases, patients will receive standard medical care, including allergen avoidance and provision of emergency medication.
- Well-controlled asthma, allergic rhinitis, and atopic dermatitis are not exclusion criteria.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Poland4 sites
Allergy Unit, Department of Pulmonary Diseases, Children's Hospital in Dziekanów Leśny
Dziekanów Leśny, Masovian Voivodeship, 05-092
Wioletta Zagórska, MD, PhD, +48 22 765 74 02, wioletta.zagorska@szpitaldziekanow.pl
Department of Pediatrics, Children's Diseases Clinic, Jagiellonian University Medical Colleg, Division of Pulmonology, Allergology and Dermatology, University Children's Hospital in Kraków
Krakow, Lesser Poland Voivodeship, 30-663
Ewa Cichocka-Jarosz, MD, PhD, +48 12 333 94 77, mijarosz@cyf-kr.edu.pl
Department of Pediatric Pulmonology, Allergology and Clinical Immunology, Institute of Pediatrics, Karol Jonscher Clinical Hospital, Poznań University of Medical Sciences
Poznan, Greater Poland Voivodeship, 60-572
Irena Wojsyk-Banaszak, MD, PhD, +48618491313, sekretpulmo@skp.ump.edu.pl
Department of Paediatric Pulmonology and Allergology, Medical University of Warsaw
Warsaw, Masovian Voivodeship, 02-091
Katarzyna Grzela, MD, PhD, +48 22 3179417, katarzyna.grzela@wum.edu.pl
About this study
Official title: An Open-Label, Multicenter, Randomized Clinical Trial Evaluating the Efficacy and Safety of Oral Multi-Food Immunotherapy With Peanut and Tree Nuts Protein Mixtures
This study aims to evaluate the efficacy and safety of multi-food oral immunotherapy (multi-OIT) using peanut and tree nuts proteins in children with confirmed food allergy to at least two allergens. Participants will be randomized in a 2:1 ratio to receive either multi-OIT or standard management consisting of an elimination diet. The primary objective is to evaluate immunotherapy efficacy defined as achieving tolerance to a cumulative dose of 4444 mg of protein during an oral food challenge (OFC-2) for at least one allergen that elicited a reaction during baseline challenge (OFC-1), compared with the control group. Secondary outcomes include the proportion of participants tolerating multiple allergens at the target cumulative dose; the incidence, type, and severity of adverse events classified according to the World Allergy Organization (WAO) grading system; changes in immunological parameters, including allergen-specific IgE and IgG4 levels; changes in skin prick test responses; changes in the quality of life of patients and their families.
Read the detailed description
This is an interventional, open-label, multicenter, randomized clinical trial enrolling 39 children aged 1-12 years with confirmed allergy to at least two of the following allergens: peanut, cashew, walnut, hazelnut and almond.
Participants will be randomized in a 2:1 ratio to either the experimental group receiving multi-food oral immunotherapy (multi-OIT) or the control group receiving standard of care consisting of an elimination diet and rescue medications. Multi-OIT will be administered using a standardized mixture of peanut and tree nuts proteins, with a dose-escalation phase followed by a maintenance phase targeting 300 mg of protein per allergen per day. Treatment duration will be approximately 18 months.
All participants will undergo oral food challenges at baseline (OFC-1) and at the end of the study (OFC-2). The primary efficacy endpoint is defined as the proportion of participants achieving tolerance to a cumulative dose of 4444 mg of protein during OFC-2 for at least one allergen that elicited a reaction during OFC-1, compared with the control group. Safety will be monitored throughout the study based on adverse events recorded in symptom diaries and classified according to established grading systems.
Secondary outcomes include the proportion of participants tolerating multiple allergens at the target cumulative dose, the frequency and severity of adverse events classified according to the World Allergy Organization (WAO) grading system, changes in immunological parameters (including allergen-specific IgE and IgG4), skin prick test responses and quality of life of patients and their families.
Participants in the control group will be offered the option to receive immunotherapy after completion of the study.
- Conditions
- Food Allergies, Food Allergy in Children, Peanut Allergies, Tree Nut Allergies, Oral Immunotherapy for Food Allergy
- Being tested
- Multi-Food Oral Immunotherapy (Multi-OIT) with Peanut and Tree Nuts Proteins, Standard of Care (Elimination Diet)
- 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.
Multi-Food Oral Immunotherapy (Multi-OIT) with Peanut and Tree Nuts ProteinsOther
Multi-food oral immunotherapy using a standardized mixture of peanut and tree nuts proteins (cashew, walnut, hazelnut, and almond), administered in a dose-escalation phase followed by a maintenance phase with a target daily dose of 300 mg of protein per allergen.
Standard of Care (Elimination Diet)Other
Standard management consisting of strict dietary avoidance of peanut and tree nuts, along with the use of rescue medications, including epinephrine, in the event of accidental allergen exposure.
| Study group | Role | What they receive |
|---|---|---|
| Multi-Food Oral Immunotherapy (Multi-OIT) | Experimental | Participants will receive multi-food oral immunotherapy (multi-OIT) using a standardized mixture of peanut and tree nuts proteins (cashew, walnut, hazelnut, and almond). Treatment includes a dose-escalation phase (1-300 mg protein per allergen) followed by a maintenance phase for 12 months (+/- 3 months) with a target daily dose of 300 mg of protein per allergen. Dose increases will be performed under medical supervision, and daily dosing will be continued at home. The total treatment duration is approximately 18 months. Receives: Other: Multi-Food Oral Immunotherapy (Multi-OIT) with Peanut and Tree Nuts Proteins |
| Standard of Care (Elimination Diet) | Active comparator | Participants will continue standard management consisting of strict elimination of peanut and tree nuts from the diet and use of rescue medications, including epinephrine, in case of accidental exposure. Participants will be monitored according to the study schedule and will undergo follow-up assessments comparable to the experimental group. Receives: Other: Standard of Care (Elimination Diet) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunotherapy Efficacy
Evaluation of immunotherapy efficacy defined as achieving tolerance to a cumulative dose of 4444 mg of protein during OFC-2 for at least one allergen that elicited a reaction during OFC-1, compared with the control group.
Measured: Up to 21 months after starting oral immunotherapy
Secondary outcomes (6)
Proportion of Participants Tolerating at least 2, 3, 4 or 5 Allergens at a Cumulative Dose of 4444 mg During OFC-2
Proportion of participants who tolerate a cumulative dose of 4444 mg of protein for at least 2, 3, 4, or 5 allergens during OFC-2 (post-treatment oral food challenge). Tolerance is defined as consumption of the full cumulative dose without dose-limiting allergic symptoms. The outcome will be summarized as the proportion of participants meeting each threshold and compared between study groups.
Measured: Up to 21 months after starting oral immunotherapy
Change in Maximum Tolerated Allergen Dose from OFC-1 to OFC-2
Change in the maximum tolerated dose (mg of protein) of allergens during oral food challenge from OFC-1 (baseline) to OFC-2 (post-treatment). The maximum tolerated dose is defined as the highest cumulative dose ingested without dose-limiting allergic symptoms. Changes will be analyzed within and between study groups.
Measured: Up to 21 months after starting oral immunotherapy
Incidence, Type and Severity of Adverse Events During Immunotherapy Compared with Control (WAO Grading)
Number, type, and severity of adverse events during immunotherapy compared with the control group, assessed based on symptom diaries and classified by severity according to the WAO scale.
Measured: Up to 21 months after starting oral immunotherapy
Change in Skin Prick Test (SPT) Wheal Diameter for Peanut and Tree Nut Allergens from Baseline to Final Assessment
Measurement of change in wheal diameter (mm) for peanut and tree nut allergens as assessed by skin prick testing (SPT) between baseline (OFC-1) and final assessment (OFC-2). Wheal size will be recorded as the mean diameter and compared within and between study groups.
Measured: Up to 21 months after starting oral immunotherapy
Change from Baseline in Allergen-Specific IgE (sIgE) and IgG4 Levels
Change in serum concentrations of sIgE and IgG4 from baseline to post-treatment assessment. Measurements will be performed using standardized immunoassays and analyzed as continuous variables to evaluate immunologic response to therapy.
Measured: Up to 21 months after starting oral immunotherapy
Change in Food Allergy-Related Quality of Life (FAQLQ)
Change in quality of life of patients and their families from baseline to post-treatment assessment, as measured using the Food Allergy Quality of Life Questionnaire (FAQLQ). Scores will be analysed as continuous variables to assess the impact of treatment on daily functioning and well-being. Scores range from 1 to 7, with higher scores indicating worse quality of life.
Measured: Up to 21 months after starting oral immunotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2031 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Food AllergiesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07764159
- Sponsor's protocol ID
- Multifood
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) that underlie the results reported in this study will be made available to qualified researchers upon reasonable request. Data requests may be submitted beginning 9 months after publication of the primary study results. Approved data will be accessible for a period of up to 24 months, with potential extensions considered on a case-by-case basis. Access will be granted to researchers conducting independent scientific research, following review and approval of a detailed research proposal and a corresponding Statistical Analysis Plan (SAP). A Data Sharing Agreement (DSA) must be executed prior to data release. For additional information or to submit a data access request, please contact: katarzyna.grzela@wum.edu.pl.
Publications
Lodge CJ, Waidyatillake N, Peters RL, Netting M, Dai X, Burgess J, Hornung CJ, Perrett KP, Tang MLK, Koplin JJ, Dharmage SC. Efficacy and safety of oral immunotherapy for peanut, cow's milk, and hen's egg allergy: A systematic review of randomized controlled trials. Clin Transl Allergy. 2023 Jul;13(7):e12268. doi: 10.1002/clt2.12268.
PubMed 37488726Pasioti M, Xepapadaki P, Mathioudakis AG, Lakoumentas J, Efstathiou E, Papadopoulos NG. Current options in the management of tree nut allergy: A systematic review and narrative synthesis. Pediatr Allergy Immunol. 2024 May;35(5):e14132. doi: 10.1111/pai.14132.
PubMed 38727626Andorf S, Manohar M, Dominguez T, Block W, Tupa D, Kshirsagar RA, Sampath V, Chinthrajah RS, Nadeau KC. Feasibility of sustained response through long-term dosing in food allergy immunotherapy. Allergy Asthma Clin Immunol. 2017 Dec 21;13:52. doi: 10.1186/s13223-017-0224-7. eCollection 2017.
PubMed 29296108Upton JEM, Toscano-Rivero D, Ke D, Berenjy A, Lejtenyi D, Beaudette L, Yin X, Li CH, Duan LY, Cohen CG, Kim V, Marzouk S, Grunebaum E, McCusker CT, Mazer B, Eiwegger T, Ben-Shoshan M. Peanut Oral Immunotherapy Using 30 and 300 mg Maintenance Doses. J Allergy Clin Immunol Pract. 2026 Jan;14(1):223-232.e7. doi: 10.1016/j.jaip.2025.10.007. Epub 2025 Oct 16.
PubMed 41109568Upton JEM, Li CH, Berenjy A, Galper A, Yin X, Celik A, Duan L, Wong S, Ditlof CM, San Diego KE, Hoang JA, Ben-Shoshan M, Kothari A, Hung L, Monteiro M, Phue WH, Moraes TJ, Eiwegger T. Safety and Efficacy of Very Low-Dose Multi-Nut Oral Immunotherapy in Children. Clin Transl Allergy. 2025 Dec;15(12):e70125. doi: 10.1002/clt2.70125.
PubMed 41385738Turner PJ, Ansotegui IJ, Campbell DE, Cardona V, Carr S, Custovic A, Durham S, Ebisawa M, Geller M, Gonzalez-Estrada A, Greenberger PA, Hossny E, Irani C, Leung ASY, Levin ME, Muraro A, Oppenheimer JJ, Ortega Martell JA, Pouessel G, Rial MJ, Senna G, Tanno LK, Wallace DV, Worm M, Morais-Almeida M; WAO Anaphylaxis Committee and WAO Allergen Immunotherapy Committee. Updated grading system for systemic allergic reactions: Joint Statement of the World Allergy Organization Anaphylaxis Committee and Allergen Immunotherapy Committee. World Allergy Organ J. 2024 Feb 10;17(3):100876. doi: 10.1016/j.waojou.2024.100876. eCollection 2024 Mar.
PubMed 38361745Sampson HA, Arasi S, Bahnson HT, Ballmer-Weber B, Beyer K, Bindslev-Jensen C, Bird JA, Blumchen K, Davis C, Ebisawa M, Nowak-Wegrzyn A, Patel N, Peters RL, Sicherer S, Spergel J, Turner PJ, Yanagida N, Eigenmann PA. AAAAI-EAACI PRACTALL: Standardizing oral food challenges-2024 Update. Pediatr Allergy Immunol. 2024 Nov;35(11):e14276. doi: 10.1111/pai.14276.
PubMed 39560049Jones SM, Kim EH, Nadeau KC, Nowak-Wegrzyn A, Wood RA, Sampson HA, Scurlock AM, Chinthrajah S, Wang J, Pesek RD, Sindher SB, Kulis M, Johnson J, Spain K, Babineau DC, Chin H, Laurienzo-Panza J, Yan R, Larson D, Qin T, Whitehouse D, Sever ML, Sanda S, Plaut M, Wheatley LM, Burks AW; Immune Tolerance Network. Efficacy and safety of oral immunotherapy in children aged 1-3 years with peanut allergy (the Immune Tolerance Network IMPACT trial): a randomised placebo-controlled study. Lancet. 2022 Jan 22;399(10322):359-371. doi: 10.1016/S0140-6736(21)02390-4.
PubMed 35065784Erdle SC, Cook VE, Cameron SB, Yeung J, Kapur S, McHenry M, Chan ES, Mak R, Rex GA, Wong T, Soller L. Real-World Safety Analysis of Preschool Tree Nut Oral Immunotherapy. J Allergy Clin Immunol Pract. 2023 Apr;11(4):1177-1183. doi: 10.1016/j.jaip.2023.01.031. Epub 2023 Feb 1.
PubMed 36736958Huang J, Puglisi LH, Cook KA, Kelso JM, Wangberg H. Safety and Feasibility of Peanut, Tree Nut, and Sesame Oral Immunotherapy in Infants and Toddlers in a Real-World Setting. J Allergy Clin Immunol Pract. 2025 Jan;13(1):185-191.e3. doi: 10.1016/j.jaip.2024.09.025. Epub 2024 Sep 30.
PubMed 39357559Begin P, Winterroth LC, Dominguez T, Wilson SP, Bacal L, Mehrotra A, Kausch B, Trela A, Hoyte E, O'Riordan G, Seki S, Blakemore A, Woch M, Hamilton RG, Nadeau KC. Safety and feasibility of oral immunotherapy to multiple allergens for food allergy. Allergy Asthma Clin Immunol. 2014 Jan 15;10(1):1. doi: 10.1186/1710-1492-10-1.
PubMed 24428859Nguyen K, Lewis MO, Hanna E, Alfaro MKC, Corrigan K, Buonanno J, Datta R, Brown-Whitehorn T, Spergel JM, Cianferoni A. Safety of Multifood Oral Immunotherapy in Children Aged 1 to 18 Years at an Academic Pediatric Clinic. J Allergy Clin Immunol Pract. 2023 Jun;11(6):1907-1913.e1. doi: 10.1016/j.jaip.2023.03.002. Epub 2023 Mar 10.
PubMed 36907355Santos AF, Riggioni C, Agache I, Akdis CA, Akdis M, Alvarez-Perea A, Alvaro-Lozano M, Ballmer-Weber B, Barni S, Beyer K, Bindslev-Jensen C, Brough HA, Buyuktiryaki B, Chu D, Del Giacco S, Dunn-Galvin A, Eberlein B, Ebisawa M, Eigenmann P, Eiwegger T, Feeney M, Fernandez-Rivas M, Fiocchi A, Fisher HR, Fleischer DM, Giovannini M, Gray C, Hoffmann-Sommergruber K, Halken S, O'B Hourihane J, Jones CJ, Jutel M, Knol EF, Konstantinou GN, Lack G, Lau S, Mejias AM, Marchisotto MJ, Meyer R, Mortz CG, Moya B, Muraro A, Nilsson C, de Oliveira LCL, O'Mahony L, Papadopoulos NG, Perrett KP, Peters R, Podesta M, Poulsen LK, Roberts G, Sampson H, Schwarze J, Smith P, Tham E, Untersmayr E, Van Ree R, Venter C, Vickery B, Vlieg-Boerstra B, Werfel T, Worm M, Du Toit G, Skypala I. EAACI guidelines on the management of IgE-mediated food allergy. Allergy. 2025 Jan;80(1):14-36. doi: 10.1111/all.16345. Epub 2024 Oct 30.
PubMed 39473345Brough HA, Caubet JC, Mazon A, Haddad D, Bergmann MM, Wassenberg J, Panetta V, Gourgey R, Radulovic S, Nieto M, Santos AF, Nieto A, Lack G, Eigenmann PA. Defining challenge-proven coexistent nut and sesame seed allergy: A prospective multicenter European study. J Allergy Clin Immunol. 2020 Apr;145(4):1231-1239. doi: 10.1016/j.jaci.2019.09.036. Epub 2019 Dec 20.
PubMed 31866098Chojnowska-Wojtowicz M, Lyzwa K, Zielinska J, Zagorska W, Grzela K. Prevalence of nut allergen sensitization among children in central Poland. Postepy Dermatol Alergol. 2023 Feb;40(1):40-46. doi: 10.5114/ada.2022.124730. Epub 2023 Feb 27.
PubMed 36909898