AuthorisedTherapeutic exploratory (Phase II)Interventional

Prospective, open-label study to analyze the efficacy and safety of low-dose oral immunotherapy in children with severe IgE-mediated cow's milk allergy treated with omalizumab. ILO study.

This research is investigating an innovative treatment for children who experience a severe, immediate allergic reaction to cow's milk. The study plans to use a medicine known as Xolair (omalizumab) alongside gradually increasing tiny amounts of cow's milk protein. The main goal is to find out if this combination can help children become less sensitive to cow's milk, allowing them to eat it with fewer or no symptoms. This type of treatment, called oral immunotherapy, aims to retrain the body's immune system. We want to see how many children can safely eat a specific amount of cow's milk protein after this treatment, compared to a placebo, without needing Xolair anymore. This could offer a new hope for managing this challenging allergy.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Hospital Infantil Universitario Nino Jesus

Enrolment target

Start

15 Sep 2023

Severe IgE-mediated cow's milk allergy

What is this study about?

This clinical trial is designed to investigate a new approach for children with a serious type of cow's milk allergy where their immune system reacts strongly. This kind of allergy involves specific antibodies called IgE, which cause immediate and sometimes severe reactions to milk. The study wants to find out if combining a medicine called Xolair (omalizumab) with a gradual introduction of tiny amounts of cow's milk can help these children become more tolerant to milk.

Xolair is a medicine given by injection that helps reduce allergic reactions. The idea behind this study is that Xolair might make it safer for children to undergo oral immunotherapy. Oral immunotherapy involves giving very small, increasing doses of the food allergen (in this case, cow's milk) over time. The aim is to help the body get used to the milk and eventually stop reacting to it so severely. By making the body less sensitive, children might be able to eat milk without dangerous symptoms, or with only very mild ones.

The main goal is to see how many children can safely eat a certain amount of cow's milk (300 milligrams, which is a tiny amount) without having serious allergic symptoms after receiving the treatment and then stopping Xolair. Researchers will compare children who receive the active treatment to those who receive a dummy treatment (placebo) in a special test, so neither the child nor the doctors will know who got what. This helps to make the results as accurate as possible.

Key takeaways

The study aims to make children with severe cow's milk allergy less reactive to milk.
It uses a medicine called Xolair combined with small, increasing doses of cow's milk.
Participation involves clinic visits, injections, and carefully supervised milk challenges.
The main goal is to see if children can tolerate 300mg of milk protein without Xolair, with minimal or no symptoms.
This research could offer a new treatment option for severe milk allergies.

Who may be eligible?

To join this study, children need to have a severe cow's milk allergy that causes immediate reactions (known as IgE-mediated). There are no specific age limits mentioned, meaning the study intends to include children across a wide age range.

More detailed checks would be done by the study team, but generally, children would need to be otherwise healthy enough to participate in the trial. They would also need to be able to safely take the study medicine and undergo tests that involve carefully introducing cow's milk.

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.

Does your child have a severe cow's milk allergy that causes immediate reactions?
Has a doctor diagnosed your child's allergy as 'IgE-mediated'?
Is your child (of any age) able to attend regular clinic visits?
Are you comfortable considering a study that involves carefully giving your child cow's milk?
Is your child generally in good health apart from their milk allergy?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, they will receive Xolair injections. The dose of Xolair will be either 75 mg or 150 mg, administered by a healthcare professional. Alongside this, your child will gradually be given very small, increasing amounts of cow's milk protein by mouth under medical supervision. This process is called oral immunotherapy.

Throughout the study, there will be several visits to the clinic for assessments and treatment. A key part of the study involves a detailed test called a 'double-blind placebo-controlled oral cow's milk challenge'. This means your child will be given either cow's milk or a dummy substance (placebo), and neither you nor the doctors will know which one it is at the time. This test helps the researchers understand the effects of the treatment accurately. There will also be follow-up tests to see how much cow's milk your child can tolerate. The total duration of participation in the study, including all treatments and follow-up, would be discussed in detail by the study team.

Potential risks and benefits

Taking part in a study like this could potentially offer your child a chance to become less allergic to cow's milk, which might improve their quality of life and reduce the fear of accidental exposure. However, there are potential risks, including allergic reactions to the cow's milk challenges, which will be managed carefully by medical staff. There might also be side effects from the Xolair medicine, which will be fully explained. You and your child are always free to withdraw from the study at any time, for any reason, without it affecting your child's future medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is Xolair (omalizumab) and how is it given?

Xolair is a medicine that helps reduce allergic reactions. It is given as an injection, usually in a pre-filled syringe by a doctor or nurse.

What does 'severe IgE-mediated cow's milk allergy' mean?

It means your child has a serious allergy to cow's milk where their body's immune system produces special antibodies called IgE, causing immediate and potentially dangerous reactions.

What is an 'oral cow's milk challenge'?

This is a carefully controlled test where your child is given measured, small amounts of cow's milk to see how their body reacts, always under close medical supervision.

Will my child automatically be able to eat any milk after the study?

The goal is to help your child tolerate some cow's milk, but the exact amount and whether they can eat any milk product freely will depend on their individual response to the treatment. This is not a guarantee of a 'cure'.

Why is this study being done?

Researchers want to find a safer and more effective way to help children with severe cow's milk allergy reduce their reactions and potentially eat some milk-containing foods without severe symptoms.