Comparing Standard and Autoclaved Peanut Oral Immunotherapy in People With Peanut Allergy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Autoclaved peanut oral immunotherapy, Blanched peanut oral immunotherapy.
- Who it may be relevant to
- Registry conditions: Peanut Allergy. Basic parameters: 4 years — 30 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Oral Immunotherapy Comparing Standard and Autoclaved Peanuts in Peanut-Allergic Individuals
Overview
Peanut allergy can cause serious and potentially life-threatening allergic reactions. Oral immunotherapy (OIT) is an investigational treatment that involves giving small, gradually increasing amounts of peanut protein to help reduce allergic sensitivity. However, OIT may cause allergic reactions during treatment. This Phase II clinical trial will compare two forms of peanut used for oral immunotherapy: standard blanched peanuts and autoclaved peanuts (peanuts heated under high temperature and pressure to modify their proteins). Participants aged 4 to 30 years with confirmed peanut allergy will be randomly assigned to receive one of the two treatments. The study will evaluate safety, tolerability, adherence, and the ability to tolerate a higher amount of peanut protein after 12 months of therapy. The goal is to determine whether autoclaved peanuts provide a safer and better tolerated approach to peanut oral immunotherapy.
Detailed description
Peanut allergy affects approximately 2% of the population and is a leading cause of food-induced anaphylaxis. Although oral immunotherapy (OIT) can increase reaction thresholds in peanut-allergic individuals, treatment-related adverse events remain common. Safer approaches to OIT are needed.
Autoclaving peanuts under controlled high-temperature and high-pressure conditions modifies peanut protein structure and reduces IgE binding. In a prior randomized double-blind oral food challenge study conducted by our group, participants tolerated significantly higher cumulative doses of autoclaved peanut compared with blanched peanut, with fewer and less severe reactions.
This is a Phase II randomized, double-blind, parallel-group clinical trial. Participants aged 4 to 30 years with confirmed IgE-mediated peanut allergy will be randomized in a 1:1 ratio to receive oral immunotherapy with either autoclaved peanuts or blanched peanuts.
The escalation phase will involve biweekly in-clinic dose increases until a maintenance dose of 300 mg peanut protein is reached, followed by 12 months of daily maintenance dosing. Double-blind, placebo-controlled food challenges will be performed at baseline, after escalation, and at study completion.
The primary endpoint is the proportion of participants in each group who tolerate a cumulative dose of 2043 mg peanut protein at the exit food challenge. Secondary endpoints include treatment-related adverse events, epinephrine use, time to maintenance, adherence, and immunologic changes.
Interventions
- Other Autoclaved peanut oral immunotherapy
Autoclaved peanut protein administered orally in gradually increasing doses during escalation phase up to 300 mg, followed by daily 300 mg maintenance dosing for 12 months. - Other Blanched peanut oral immunotherapy
Standard blanched peanut protein administered orally in gradually increasing doses during escalation phase up to 300 mg, followed by daily 300 mg maintenance dosing for 12 months.
Primary outcome measures
- Proportion of Participants Tolerating 2043 mg Peanut Protein at Exit Double-Blind Placebo-Controlled Food Challenge [Time frame: At 12 months after initiation of maintenance phase]
Eligibility criteria
Inclusion criteria
- Peanut-allergic subjects between the ages of 4 and 30 years old who satisfy all the following criteria will be included:
- A history suggestive of immediate IgE-mediated peanut allergy (more than 2 mild symptoms or more than 1 moderate or severe symptom within 120 minutes of ingestion or contact).
- Confirmation of peanut allergy with at least one of the following:
- Positive SPT to peanut (wheal equal of more than 3 mm above saline control).
- Serum specific IgE equal or more than 0.35 kU/L to peanut or peanut components.
- Previous positive oral food challenge to peanut (raw, roasted or blanched) according to EAACI guidelines.
- Positive DBPCFC to blanched peanut at screening.
- Signed informed consent (parental/legal guardian consent if under 18 years old).
Exclusion criteria
- • Unstable asthma or uncontrolled chronic respiratory disease.
- Active infectious or inflammatory conditions.
- Non-IgE-mediated or non-immunological adverse reactions to peanuts.
- Patients receiving immunosuppressor therapy.
- Patients receiving β-blockers (including topical formulations).
- Associated diseases contraindicating the use of epinephrine: cardiovascular disease or uncontrolled hypertension.
- Eosinophilic gastrointestinal disorder.
- Any other condition that, in the opinion of the investigators, poses excessive risk or interferes with protocol adherence.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- The Centre for Innovative Medicine (CIM) at the Montreal Children's Hospital (MCH) — Montreal
Identifiers
NCT: NCT07439406 · 2026-12039