RecruitingNAINTERVENTIONAL

Investigating Modified Protocols of Oral Immunotherapy to Validate Efficacy and Safety

This study is investigating new and potentially safer ways to treat common and serious food allergies, such as those to peanuts, milk, and eggs. Currently, treatments exist where patients slowly eat tiny, increasing amounts of the food they're allergic to, but this can sometimes cause allergic reactions. Researchers want to see if using even smaller starting doses of these foods, or giving them in a processed form (like baked milk instead of liquid milk), can still make people less allergic while causing fewer uncomfortable side effects. The aim is to find effective treatments that are also more comfortable and less risky for patients during the treatment process.

At a glance

Status

Recruiting

Phase

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Enrolment target

360

Start

01 Mar 2022

Estimated completion

28 Feb 2030

Peanut Allergy Milk Allergy, Cow's Egg Allergy

What is this study about?

Imagine being severely allergic to certain foods like peanuts, milk, or eggs, where even a tiny bit could make you very ill. Medical science has developed treatments called Oral Immunotherapy (OIT), where doctors carefully give patients increasing amounts of the food they're allergic to. Over time, this can help their body learn to tolerate the food better, reducing the chance of a serious reaction.

While these treatments are helpful and accepted by health guidelines in Europe and Canada, both doctors and patients have been a bit worried about them. This is because there's a risk of having an allergic reaction during the treatment itself. This new study wants to make these treatments better and safer.

Researchers in this study are exploring a new approach. They want to find out if giving very low doses of the allergen, or using processed versions of the food (like cooked milk in a baked item instead of liquid milk), can still achieve the same positive results. The main goal is to protect people from their allergies while significantly reducing the number of allergic reactions patients might experience during the treatment process. This could make food allergy treatment much more comfortable and less daunting for patients.

Key takeaways

Exploring safer ways to treat severe food allergies.
Focus on peanut, milk, and egg allergies.
Testing if very low doses or processed foods reduce treatment side effects.
Aims to make allergy treatment more comfortable and effective.
Participants must have a confirmed, immediate-type food allergy.
Not suitable for individuals with certain health conditions or medications.

Who may be eligible?

To join this study, you generally need to be between 2 and 40 years old. You must have a clear history of a sudden allergic reaction (like hives, swelling, or breathing issues) to peanut, milk, or egg that happened quickly after eating or touching the food. This allergy also needs to be confirmed by specific allergy tests, like a skin prick test showing a raised bump, or a blood test checking for allergy antibodies.

However, there are reasons you might not be able to join. For example, if you have severe asthma or another uncontrolled breathing problem, or if you already have a serious illness that affects your immune system. You also wouldn't be able to participate if your allergy isn't a typical 'IgE-mediated' allergy (the kind that causes immediate reactions).

Other reasons for not being able to join include if you are taking certain heart medications (like beta-blockers), if you have certain heart conditions, or if you have specific stomach or gut problems like eosinophilic oesophagitis. Finally, if you already eat cooked forms of the allergic food without any problems (for example, if you can eat a cake containing milk), this study might not be suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 2 and 40 years old?
Do you have a clear history of an immediate, severe reaction to peanut, milk, or egg?
Has your allergy been confirmed by a skin prick or blood test?
Do you *not* have uncontrolled asthma or other severe breathing problems?
Are you *not* taking certain heart medications (like beta-blockers)?
Do you *not* already eat baked or cooked forms of the allergic food without issues?

Answer every question to see your result.

What does participation involve?

The detailed steps for participating in this specific study are not provided in this summary. However, typically for studies like this, you would have an initial screening to check if you meet all the requirements. If eligible, you would likely have regular visits to a clinic where doctors would carefully give you very small, increasing amounts of the food you are allergic to. This process is done under close medical supervision to ensure your safety. You would need to follow a strict diet and avoid certain medications. The study would involve ongoing check-ups and monitoring for any allergic reactions or side effects. The total duration of the study is not specified but similar treatments can last several months to a few years.

Potential risks and benefits

Participating in this study could potentially offer significant benefits. If successful, you might become less allergic to the food, meaning accidental exposure could lead to milder reactions or no reaction at all, greatly improving your quality of life and reducing anxiety. However, there are risks, primarily the possibility of experiencing an allergic reaction during the treatment, which could range from mild to severe, even though the study aims to reduce these. Serious reactions would be managed immediately by medical staff. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Research Institute of the McGill University Health Centre
Verified postcode
Montreal, Canada· Recruiting

Common questions

What kind of allergies is this study looking at?

This study is focused on severe allergies to peanuts, milk, and eggs.

What is 'Oral Immunotherapy'?

It's a treatment where you slowly eat tiny, increasing amounts of the food you're allergic to, to help your body become less sensitive.

Why are they doing this new study?

They want to find ways to make Oral Immunotherapy safer and cause fewer allergic reactions during treatment.

Who can't join this study?

People with uncontrolled asthma, certain heart issues, specific gut problems, or those already tolerating cooked forms of the allergic food typically can't join.

Will I have an allergic reaction if I join?

The study aims to reduce reactions, but there's always a risk in allergy treatment. You'll be closely monitored by doctors.

How to find out more

Duncan Lejtenyi, M.Sc

duncan.lejtenyi@muhc.mcgill.ca 1-514-934-1934 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.