An interventional study of Oral immunotheraphy (OIT) in Food Allergy in Children and Oral Immunotherapy for Food Allergy, sponsored by Copenhagen Studies on Asthma in Childhood. Not yet recruiting at 1 site in Denmark. Open to participants aged Up to 24 Months. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Copenhagen Studies on Asthma in Childhood · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn whether oral immunotherapy (OIT) is safe and effective for treating food allergy in children aged 0-2 years with peanut, tree nut, or sesame allergy. The study also aims to identify biological mechanisms and biomarkers associated with natural tolerance development and successful OIT using a systems biology approach.
The main questions it aims to answer are:
Researchers will compare children receiving oral immunotherapy with children receiving standard care (allergen avoidance) to determine differences in treatment success, sustained unresponsiveness, safety, quality of life, and biological markers.
Participants will:
Food allergy affects approximately 4% of children worldwide and has increased over the past two decades, imposing substantial psychosocial and economic burden on affected families. For years, management relied on strict avoidance of the allergen and carrying an epinephrine autoinjector, which leads to tolerance development among 10-30% with peanut, tree-nut and sesame allergy. Treatments for food allergy such as biologics and oral immunotherapy (OIT) have shown a promising safety and efficacy profile in most studies, especially in younger children, but are not yet standard of care.
Biologics, including monoclonal antibodies targeting IgE (such as omalizumab) or key type 2 inflammatory pathways (e.g. dupilumab), offer an emerging strategy for managing food allergy. Used as stand-alone therapy, biologics can raise the threshold for allergic reactions and reduce symptom severity. Moreover, biologics have also been studied as adjuncts to OIT, where they may improve safety profiles, reduce dosing-related reactions, and facilitate more rapid desensitization. However, trials in young children assessing both safety, efficacy, mechanism and potential biomarkers are needed to inform personalized strategies, determining which children might benefit most from an avoidance strategy, OIT alone, biologics alone, or a combined approach. Currently, Palforzia is the only European Medicines Agency (EMA) approved OIT product available and approved for children from 4-17 years of age, whereas there are no OIT treatment options for the youngest children, where the prevalence of food allergy is highest.
Peanut OIT is gaining support based on real-world evidence, but OIT RCTs in young children under age 6 years are scarce and limited to studies of peanut and egg. The short term desensitization rates following peanut OIT range from 60% to 85%, and are higher when treatment begins in preschool age. Gastrointestinal and respiratory symptoms are common during peanut OIT, whereas rates of anaphylaxis requiring epinephrine are varying but relatively low, where up to 14% has been reported. Data for tree-nut OIT, e.g., hazelnut, cashew, pistachio, walnut and almond, is limited to a single-center retrospective study on hazelnut OIT in children \< 18 years, and a single-center prospective cohort study on walnut OIT in children from 4-20 years. Further, data on tree-nut allergy has been extrapolated from an omalizumab-supported multifood OIT study in children from 4-15 years, which included cashew, walnut, hazelnut, and almond. Although outcomes and study design varied considerably, short term desensitization following tree-nut OIT ranged from 34% to 100%. Analysis of preliminary safety data is promising, with primarily mild reactions comparable with peanut OIT. Evidence for sesame OIT is very limited and solely based on small observational cohorts, case series, or extrapolated from multifood OIT protocols including sesame. Reported short term desensitization rates vary from 55% to 80%, and the majority of adverse reactions are mild.
Thus, while short term safety and efficacy of peanut, tree-nut, and sesame OIT seems promising, RCTs are needed in the youngest children, where food allergy is most prevalent. Moreover, although short term desensitization rates are encouraging, long term tolerance to the food - known as sustained unresponsiveness after discontinuing OIT - has proven more elusive. Follow-up studies show that many children relapse once therapy ends. Thus, there is a need for studies to identify underlying mechanisms and biomarkers predicting sustained unresponsiveness versus relapse, i.e. personalized treatment. In addition, some children will outgrow their food allergy during avoidance, i.e., natural tolerance development, but the mechanisms underlying natural tolerance are poorly understood, and no reliable predictors exist. Further, open-label quality-of-life (QoL) studies have consistently shown that OIT substantially reduces family anxiety concerning accidental exposures and improves daily functioning, but this still needs to be investigated in the youngest children in RCTs with a proper comparison of children undergoing avoidance vs. OIT. Finally, no previous study has investigated facilitators and barriers for implementing OIT in clinical practice, despite its higher resource demands and higher risk of adverse reactions compared to standard of care.
376 studies on the registry are indexed under Food Hypersensitivity; 90 are open to participants now.
This study's planned enrollment of 120 is above the median of 60 across 246 interventional studies indexed under Food Hypersensitivity.
Browse Food Hypersensitivity studies →Copenhagen Studies on Asthma in Childhood is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
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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.
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.
Participants will receive oral immunotherapy (OIT) for their diagnosed food allergy to peanut, tree nuts, or sesame.
Dietary Supplement: Oral immunotheraphy (OIT)
Participants randomized to the control arm will follow standard of care consisting of avoidance of the relevant food allergen.
Daily OIT will be administered with the relevant food allergen. Treatment includes gradual dose escalation over approximately 6 months, followed by a 12-month maintenance phase with daily intake of 300 mg food protein. Assessment of sustained unresponsiveness: Following completion of OIT and a successful end-of-treatment oral food challenge, participants in the OIT arm will undergo a second 1:1 randomization to either continued regular allergen consumption or allergen avoidance. After an additional 6 months, participants will undergo another oral food challenge to assess sustained unresponsiveness.
Oral Food Challenge Response at End of Treatment
Effect of oral immunotherapy will be assessed by oral food challenge (OFC) at the end of treatment and compared with the control arm. Participants will be classified into predefined response categories: successful responders, defined as participants tolerating a 4000 mg food protein OFC; partial responders, defined as participants with an increased reaction threshold to at least 1000 mg food protein but not tolerating the final 4000 mg OFC and/or experiencing difficulties during up-dosing; and non-responders, defined as participants discontinuing OIT due to allergic reactions or having a reaction threshold below 1000 mg food protein.
Time frame: End of treatment, approximately 18-24 months after randomization
Difficulty With Up-dosing During Oral Immunotherapy
Difficulty with up-dosing will be assessed in participants randomized to the OIT group. Difficulty is defined as allergic reactions, dose reductions, delayed dose escalation, temporary treatment interruption, or inability to complete the planned up-dosing phase according to protocol.
Time frame: During the up-dosing phase, approximately 0-6 months after treatment initiation.
Sustained Unresponsiveness
Sustained unresponsiveness will be assessed by oral food challenge (OFC) after 6 months of either avoidance or regular intake of the allergenic food, according to randomization after completion of OIT. Success of the OFC will indicate potential long-term tolerance rather than transient desensitization.
Time frame: 24-30 months after initial randomization, corresponding to approximately 6 months after completion of OIT.
Change in Gut Microbiome Diversity Assessed by Shannon Index
Change from baseline to end of treatment in gut microbiome diversity, assessed using the Shannon Index based on shotgun metagenomic sequencing of stool samples. Changes over time will be assessed within treatment groups and compared between treatment groups.
Time frame: Baseline to end of treatment, approximately 18-24 months after randomization.
Change in Fecal Metabolite Levels
Changes from baseline to end of treatment in fecal metabolite levels will be assessed using untargeted metabolomic profiling of stool samples. Changes in metabolite levels over time will be assessed within treatment groups, and differences in these changes will be compared between treatment groups.
Time frame: Baseline to end of treatment, approximately 18-24 months after randomization.
Change in Blood Immunoglobulin Markers
Changes from baseline to end of treatment in blood immunoglobulin markers, including food-specific IgG1 and IgG4 and total IgE, will be assessed. Changes over time will be assessed within treatment groups and compared between treatment groups.
Time frame: Baseline to end of treatment, approximately 18-24 months after randomization.
Change in Mast Cell Activation
Change from baseline to end of treatment in mast cell activation in response to peanut, sesame, and tree nuts will be assessed using the Mast Cell Activation Test (MAT). Changes over time will be assessed within treatment groups and compared between treatment groups.
Time frame: Baseline to end of treatment, approximately 18-24 months after randomization.
Change in Plasma Metabolite Levels
Changes from baseline to end of treatment in plasma metabolite levels will be assessed by metabolomic profiling using Liquid Chromatography-Mass Spectrometry (LC-MS) and Gas Chromatography-Mass Spectrometry (GC-MS) using the Global HD4 platform at Metabolon Inc., US. Changes in metabolite levels over time will be assessed within treatment groups, and differences in these changes will be compared between treatment groups.
Time frame: Baseline to end of treatment, approximately 18-24 months after randomization.
Rate and Severity of Allergic Reactions During Oral Immunotherapy
The number and severity of anaphylaxis and other allergic reactions during OIT will be recorded at build-up visits and maintenance follow-up visits, including symptoms since the last visit, missed doses, accidental exposures, relevant cofactors, and treatments required. Reactions will be graded according to a modified World Allergy Organization grading system, grades 1 to 5, with adaptations specific to allergic reactions in infants.
Time frame: From initiation of OIT to end of treatment, approximately 18-24 months after randomization.
Change in Parental Food Allergy-associated Anxiety and Coping
Changes in parental food allergy-associated anxiety, coping, and impact on daily life will be assessed using the Impairment Measure for Parental Food Allergy-Associated Anxiety and Coping Tool (IMPAACT). The questionnaire will be completed by parents at baseline and at the end of the randomized controlled trial, and changes will be assessed within and between treatment groups.
Time frame: Baseline to end of treatment, approximately 18-24 months after randomization.
Change in Allergic Sensitization
Changes in allergic sensitization to the relevant food allergen will be assessed by specific IgE and skin prick testing.
Time frame: Baseline to end of treatment, approximately 18-24 months after randomization.
Development of New Allergic Sensitizations and Atopic Manifestations
The development of new food or inhalant sensitizations and new atopic manifestations will be assessed and compared between treatment groups. Atopic manifestations may include wheeze, allergic rhinitis, and atopic dermatitis. Atopic dermatitis will be assessed using established diagnostic criteria and severity scoring.
Time frame: Baseline to end of treatment, approximately 18-24 months after randomization.
Prediction of Sustained Unresponsiveness
Different omics layers will be used to explore whether sustained unresponsiveness can be predicted.
Time frame: Baseline to assessment of sustained unresponsiveness, approximately 24-30 months after randomization.
Change in PBMC Gene Expression Profiles
Changes from baseline to end of treatment in gene expression profiles will be assessed in peripheral blood mononuclear cells (PBMCs). Changes in gene expression over time will be assessed within treatment groups and compared between treatment groups and may additionally be evaluated as part of exploratory multivariate and multi-omics analyses.
Time frame: Baseline to end of treatment, approximately 18-24 months after randomization.
Change in PBMC Epigenetic Profiles
Changes from baseline to end of treatment in epigenetic profiles will be assessed in peripheral blood mononuclear cells (PBMCs). Changes in epigenetic markers over time will be assessed within treatment groups and compared between treatment groups and may additionally be evaluated as part of exploratory multivariate and multi-omics analyses.
Time frame: Baseline to end of treatment, approximately 18-24 months after randomization.
Plan to share: Yes — Individual participant data that underlie the results reported in publications (after de-identification), together with the study protocol, statistical analysis plan, and data dictionary, will be made available upon reasonable request to the corresponding author, subject to approval of a data access agreement and applicable ethical and legal requirements.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Beginning 12 months following publication of the primary results and ending 5 years after publication.
Access criteria: Data will be available to researchers who provide a methodologically sound proposal for achieving the aims of the approved proposal. Proposals will be reviewed by the study investigators and access will require a signed data access agreement.
Start is estimated for Sep 2026; primary completion for Mar 2031, 54 months later.
Of 81 non-industry interventional studies with no phase under Food Hypersensitivity, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 50. This study's planned 54 months is above that.
Counting every sponsor, half of 84 studies reached it within 29 months; a quarter within 13 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Copenhagen Studies on Asthma in Childhood