RecruitingOBSERVATIONAL

Observatory of the Lille Paediatric Allergy Unit

This study, based at the Lille Paediatric Allergy Unit in France, aims to learn more about how children with food allergies respond to a treatment called 'oral immunotherapy'. This treatment involves carefully giving small, increasing amounts of the food a child is allergic to, hoping to reduce their reactions over time. Researchers will keep a close eye on children under 16 who are starting this therapy for common allergens like nuts, cow's milk, wheat, or eggs, as well as some less common ones. They will collect information during regular hospital visits and ask parents to keep a diary of any reactions. The goal is to gather detailed data to better understand how oral immunotherapy works for different allergies.

At a glance

Status

Recruiting

Sponsor

Lille Catholic University

Enrolment target

1,000

Start

01 Jan 2022

Estimated completion

31 Dec 2024

Child Allergy IgE-Mediated Allergic Process Food Allergy

What is this study about?

This study is happening at the children's allergy clinic in Saint Vincent Hospital in Lille, France. Its main purpose is to watch and learn from children who are starting a special treatment for their food allergies called 'oral immunotherapy'. This treatment is all about carefully introducing tiny amounts of the food a child is allergic to, gradually increasing the amount over time. The idea is to help their body become less sensitive to the food, so they can tolerate it better or even eat it without a severe reaction.

The research team will collect lots of information about children under 16 who are going through this treatment. They are particularly interested in common allergens like hazelnuts, cashews, pistachios, peanuts, cow's milk, wheat, and eggs, but also some less common ones like sesame or peas. By carefully tracking how each child responds, they hope to gain a much better understanding of how oral immunotherapy works in real-life situations, what factors make it successful, and what potential challenges might arise.

This important information will help doctors improve care for children with food allergies in the future, making treatments safer and more effective. It's like building a big puzzle with many pieces of information from different children to see the whole picture of how this treatment works.

Key takeaways

This study helps doctors learn about oral immunotherapy for food allergies.
It focuses on children under 16 with diagnosed food allergies.
Children will receive immunotherapy for allergens like nuts, milk, or eggs.
Regular hospital visits and a home diary are part of participating.
The goal is to gather data to improve future allergy treatments.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for children aged under 16 years old who have a clear diagnosis of a food allergy. This diagnosis would have been confirmed by a 'food challenge test' (where they are given the food under medical supervision) or if their doctors are very sure they have an allergy based on their history and other tests.

The child must also be considered suitable for oral immunotherapy, which is a treatment where they gradually eat tiny amounts of the allergen. They should be allergic to one of the following foods: hazelnut, walnuts, pistachios, cashew nuts, peanuts, cow's milk, wheat, eggs, sesame, celery, fenugreek, peas, or lentils, or other similar foods.

Children cannot take part if they have already had oral immunotherapy for the same food allergy, or if their parents or guardians do not wish them to participate.

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.

Is your child under 16 years old?
Does your child have a definite diagnosis of a food allergy?
Has your child's doctor said they are suitable for oral immunotherapy?
Is your child allergic to one of the specific foods mentioned (e.g., nuts, milk, eggs, wheat, sesame, etc.)?
Has your child *not* already had oral immunotherapy for the specific food allergy being considered?

Answer every question to see your result.

What does participation involve?

If your child takes part, the allergy doctor will explain the study to you and your child, and you'll get a detailed information sheet. Your child will then be placed into one of three groups based on their allergy (e.g., nut allergies, milk/wheat/egg allergies, or other food allergies).

Oral immunotherapy will begin with a carefully supervised session in the hospital. You will be given a diary to fill in at home, noting any reactions your child might have to the treatment. You and your child will have regular check-ups, usually every six months, with a flexible two-month window around these dates. During these visits, the doctors will continue to collect information about your child's health and how the treatment is going.

Sometimes, the doctor might suggest another food challenge test during a visit to see how much of the food your child can now safely eat. This helps them understand how well the desensitisation (reducing sensitivity) is working. The study will continue until your child reaches a point where they are desensitised or if you decide to stop the treatment. If your child has several allergies, they can be part of the study for each one.

Potential risks and benefits

Taking part in this study means your child will receive oral immunotherapy, which aims to reduce their sensitivity to certain foods and potentially improve their quality of life by making accidental exposure less dangerous. However, oral immunotherapy always carries a risk of allergic reactions, which can range from mild (like hives or tummy upset) to more severe. The hospital team will closely monitor your child, especially during the initial stages and any challenge tests, to manage these risks. You have the right to withdraw your child from the study and stop the oral immunotherapy protocol at any time, for any reason, without it affecting their usual medical care.

Locations (1)

Groupement de l'Institut Catholique de Lille - Hôpital Saint Vincent de Paul
Verified postcode
Lille, France· Recruiting

Common questions

What is 'oral immunotherapy'?

It's a treatment where a child gradually eats very small, increasing amounts of a food they are allergic to, hoping their body will become less sensitive to it over time.

Which types of allergies are included?

Common ones like nuts, cow's milk, wheat, and eggs, but also some less common foods like sesame or lentils.

How often will we need to visit the hospital?

You'll have regular check-ups, typically every six months, but the specific schedule for the initial build-up phase will be explained by your doctor.

What do I need to do at home?

You'll be asked to keep a diary to record any reactions your child has during their daily oral immunotherapy at home.

Can my child stop the study if they want to?

Yes, you or your child can decide to stop participating in the study and the oral immunotherapy at any time, for any reason.

How to find out more

Domitille Tristram

tristram.domitille@ghicl.net + 33 3 20 22 57 37 Official trial record

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