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Can Super-Heated peanuts make allergy treatment safer?

NCT ID NCT07439406

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 trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 2 trial tests two forms of peanut oral immunotherapy in 57 people aged 4 to 30 with peanut allergy. One group gets standard blanched peanut protein, the other gets autoclaved (high-pressure heated) peanut protein, both in gradually increasing doses. The goal is to see if autoclaved peanuts are safer and better tolerated while still helping participants tolerate a larger amount of peanut (about 8 peanuts) after 12 months of daily treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Peanut protein (autoclaved or blanched) given as oral immunotherapy
What this could lead to
If it works, this could offer a safer way to desensitize people with peanut allergy, reducing the risk of severe reactions from accidental exposure.
What could go wrong
This is a small Phase 2 trial, so results may not apply to everyone. Oral immunotherapy can still cause allergic reactions, and the treatment requires daily maintenance dosing.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 57 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2028

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

4 to 30 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: * 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.

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Conditions

The condition(s) this trial relates to.

food allergy Peanut Hypersensitivity

As listed by the trial registrant

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

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

  • The Centre for Innovative Medicine (CIM) at the Montreal Children's Hospital (MCH)

    Montreal, Quebec, H4A 3J1, Canada

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