A Randomized Controlled Trial of Oral Immunotherapy Versus Allergen Avoidance in Children Under 2 Years With Food Allergy

NCT07825662 | Not Yet Recruiting

• 1 other identifier: H-25096489
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• Be randomized to either oral immunotherapy or allergen avoidance for 18-24 months.
• Undergo oral food challenges at study visits to assess allergic reactivity and treatment outcomes.
• Provide blood, urine, hair, skin swabs, skin tape strips, throat swabs, nasal lining fluid, and stool samples at baseline and at the end of the study for immune, microbiome, metabolomic, gene expression, and epigenetic analyses.
• Complete allergy assessments, including skin prick testing and clinical evaluations.
• Have allergic symptoms, adverse reactions, and development of other allergic diseases monitored throughout the study.
• Have parents complete questionnaires assessing food allergy-related quality of life, anxiety, and coping.

Conditions

Oral Immunotherapy for Food Allergy; Food Allergy in Children

Keywords

Food allergy; Oral immunotherapy; Children; Peanut Hypersensitivity; Sesame Hypersensitivity; Treenut Hypersensitivity; Immunotherapy; Peanut allergy; Sesame allergy; Tree nut allergy

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  24-30 months after initial randomization, corresponding to approximately 6 months after completion of OIT.

Secondary Outcomes (12)

• Change in Gut Microbiome Diversity Assessed by Shannon Index

  Baseline to end of treatment, approximately 18-24 months after randomization.

• Change in Fecal Metabolite Levels

  Baseline to end of treatment, approximately 18-24 months after randomization.

• Change in Blood Immunoglobulin Markers

  Baseline to end of treatment, approximately 18-24 months after randomization.

• Change in Mast Cell Activation

  Baseline to end of treatment, approximately 18-24 months after randomization.

• Change in Plasma Metabolite Levels

  Baseline to end of treatment, approximately 18-24 months after randomization.

Study Arms (2)

Intervention arm

EXPERIMENTAL

Participants will receive oral immunotherapy (OIT) for their diagnosed food allergy to peanut, tree nuts, or sesame.

Dietary Supplement: Oral immunotheraphy (OIT)

Control arm

NO INTERVENTION

Participants randomized to the control arm will follow standard of care consisting of avoidance of the relevant food allergen.

Interventions

Oral immunotheraphy (OIT) DIETARY_SUPPLEMENT

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.

Intervention arm

Eligibility Criteria

• Age: Up to 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children age 0-2 years
• Both parents provide informed consent

You may not qualify if:

• Already undergoing any form of immunotherapy
• Already undergoing any form of biological treatment
• Medical conditions precluding OITs: Uncontrolled asthma, atopic dermatitis requiring systemic therapy, eosinophilic esophagitis (EoE) and other GI-diseases, other severe immunological diseases (e.g. inborn errors of immunity )

Sponsors & Collaborators

• Copenhagen Studies on Asthma in Childhood: lead
• Herlev and Gentofte Hospital: collaborator

Study Sites (1)

Department of Paediatrics, Herlev Hospital

Herlev, Capital Region, 2730, Denmark

Location

Related Publications (35)

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MeSH Terms

Conditions

Food Hypersensitivity; Peanut Hypersensitivity; Nut Hypersensitivity

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Bo Chawes

CONTACT

+4538681152; chawes@copsac.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomized 1:1 to oral immunotherapy (OIT) or allergen avoidance. Following completion of OIT and successful end-of-treatment oral food challenge, participants in the OIT arm undergo a second randomization to either continued regular allergen consumption or allergen avoidance for assessment of sustained unresponsiveness.

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 17, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): June 1, 2031
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, 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.

Locations

DK (1)