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New study aims to make food allergy treatment safer and more tolerable

NCT ID NCT06256146

Disease control Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests modified oral immunotherapy (OIT) protocols for peanut, milk, and egg allergies in 360 participants. The goal is to see if using lower doses or processed allergens can reduce allergic reactions during treatment while still helping people become desensitized to their allergen. The study compares different OIT approaches to find a safer, more tolerable option.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 360 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2022

Expected to finish

Feb 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 40 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * A history suggestive of immediate allergy to the food. A convincing clinical history of an IgE mediated reaction to a specific food will be defined as a minimum of 2 mild signs/symptoms or 1 moderate or 1 severe sign/symptom that was likely IgE mediated and occurred within 120 minutes after ingestion or contact * The presence of at least one of the following confirmatory tests: * Positive SPT to the culprit food allergen (weal diameter 3 mm larger than that of the normal saline control). The allergens used will be commercial extracts of the foods (Omega Labs, Toronto, Ontario). * Detection of serum specific IgE (\>0.35 kU/L) to the culprit food or any of its proteins, measured by fluorescence enzyme immunoassay (Phadia, CAP System, Uppsala, Sweden). Exclusion Criteria: * Patients who have uncontrolled respiratory disease (asthma, cystic fibrosis, etc.) * Patients who present with intercurrent disease active at the time of starting desensitization. * Non IgE mediated or non-immunological adverse reactions to milk or peanuts. * Malignant or immunopathological diseases and/or severe primary or secondary immune deficiencies. * Patients receiving oral immunosuppressor therapy. * Patients receiving β-blockers (including topical formulations), or who receive daily doses of NSAIDs, aspirin or ACE inhibitors for cardiac issues. * Associated diseases contraindicating the use of epinephrine: cardiovascular disease, severe hypertension or hypotension. * Patients diagnosed with eosinophilic gastrointestinal disorders, including patients with a history of antacid use for reflux related to food impaction or with a history of esophageal spasm. * Patients already tolerating processed/cooked forms of the food (e.g.,baked goods with milk).

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Conditions

The condition(s) this trial relates to.

Egg Hypersensitivity food allergy Heiner syndrome Milk Hypersensitivity Peanut Hypersensitivity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Egg allergy Milk allergy, cow's Peanut allergy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Research Institute of the McGill University Health Centre

    RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.