Comparing Standard and Autoclaved Peanut Oral Immunotherapy in People With Peanut Allergy
This study is for 4- to 30-year-olds with a peanut allergy. We're looking at a new treatment called "oral immunotherapy" (OIT), which involves carefully eating small, increasing amounts of peanut over time. The goal is to help your body become less sensitive to peanuts. We're comparing two different preparations of peanuts: standard peanuts and peanuts that have been heated under high pressure (autoclaved). We want to find out if the specially heated peanuts are safer, cause fewer side effects, and help people tolerate more peanut protein after 12 months. This is a "Phase II" study, meaning we're testing safety and how well it works before larger studies.
At a glance
What is this study about?
Peanut allergy can be very serious, and for some people, just a tiny bit of peanut can cause a severe reaction. At the moment, the main way to manage peanut allergy is to avoid peanuts completely and carry emergency medicine like an adrenaline auto-injector.
Researchers are always looking for new and safer ways to treat peanut allergy. One approach is called "oral immunotherapy" (OIT). This treatment involves carefully giving a person with a peanut allergy very small, gradually increasing amounts of special peanut protein over time. The idea is to slowly train the immune system to become less sensitive to peanuts, so accidental exposure might not cause such a bad reaction.
This particular study is a "Phase II" trial, which means it’s an early-stage study focusing on whether a treatment is safe and how well it works. Here, we're comparing two forms of peanut for OIT: standard blanched peanuts and 'autoclaved' peanuts. Autoclaved peanuts are regular peanuts that have been heated under high temperature and pressure. This special heating process changes the peanut proteins, and we think it might make them less likely to cause a reaction during treatment. The study aims to see if these autoclaved peanuts offer a safer and better experience for people undergoing OIT compared to standard peanuts.
Key takeaways
- It's for 4- to 30-year-olds with peanut allergy.
- Compares two types of peanuts for a new treatment.
- Aims to make people less sensitive to peanuts.
- Involves carefully eating small, increasing amounts of peanut.
- Could involve allergic reactions, managed by the study team.
- Participation lasts over 12 months, with regular clinic visits.
Who may be eligible?
To join this study, you need to be between 4 and 30 years old and have a confirmed peanut allergy. This means your doctors have done tests and found clear signs that your immune system reacts to peanuts. You might have had a strong reaction to peanuts before, or blood/skin prick tests show you have specific antibodies to peanuts.
There are also some reasons why you might not be able to join. For example, if you have asthma that isn't well controlled, certain ongoing infections, or other serious health conditions like heart problems. Also, if you're taking specific medications like 'beta-blockers' or medicines that affect your immune system, you wouldn't be able to participate. The study team will check all these details carefully with you and your family doctor.
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 4 and 30 years old?
- Do you have a clear diagnosis of peanut allergy?
- Do you have well-controlled asthma, if you have it?
- Are you currently taking any medications that suppress your immune system or beta-blockers?
What does participation involve?
If you join the study, you'll be randomly assigned to receive either standard peanuts or the specially heated (autoclaved) peanuts. You won't know which one you're getting, nor will the study doctors. Initially, you'll have regular visits to the clinic, usually every two weeks, where your dose of peanut protein will be slowly increased under medical supervision. Once you reach a certain dose (called the maintenance dose), you'll take this amount daily at home for 12 months.
Throughout the study, you'll have specific check-ups and tests. This includes 'food challenges' at the beginning, after the dose increases, and at the end of the study. During a food challenge, you'll eat carefully measured amounts of peanut in a safe hospital setting to see how much you can tolerate. The study will last for a total of 12 months after you reach your daily maintenance dose, plus the initial period of increasing your dose.
Potential risks and benefits
Locations (1)
- The Centre for Innovative Medicine (CIM) at the Montreal Children's Hospital (MCH)Verified postcodeMontreal, Canada
Common questions
What is oral immunotherapy (OIT)?
OIT is a treatment where you eat very small, increasing amounts of a food you're allergic to, hoping to make your body less sensitive to it.
What's the difference between standard and autoclaved peanuts?
Autoclaved peanuts are regular peanuts that have been specially heated under high pressure, which changes their proteins. We're hoping this makes them safer for OIT.
Will I know if I'm getting the standard or autoclaved peanuts?
No, this is a 'double-blind' study, meaning neither you nor the study team will know which type of peanut you're receiving until the study is over.
How long will the study last?
The study involves a period of increasing doses, followed by 12 months of daily treatment at home, plus several clinic visits and food challenges.
Can I still get an allergic reaction during the study?
Yes, allergic reactions are possible during OIT. The study team will be prepared to manage any reactions that occur.
How to find out more
Bruce Mazer, Dr.
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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