Active not recruitingNAINTERVENTIONAL

Using Commonly Available Food Products To Treat Food Allergy

The NATASHA study is looking into new ways to treat serious food allergies, specifically to peanuts and cow's milk, which often cause life-threatening reactions in children. This research uses an approach called oral immunotherapy (OIT). This means giving very small, increasing amounts of the food allergen to help the body get used to it over time. The goal is to reduce or stop allergic reactions when someone accidentally eats allergy-causing food. This study will involve young people aged 3 to 23 who have peanut or cow's milk allergies. They will carefully eat everyday foods containing their allergen under medical supervision. Besides checking if the treatment works and is safe, the study will also gather information to see if this method is good value for money in the UK over the long term.

At a glance

Status

Active not recruiting

Phase

Sponsor

University of Southampton

Enrolment target

216

Start

19 Jan 2023

Estimated completion

31 Aug 2029

IgE-Mediated Cow Milk Allergy Peanut Allergy

What is this study about?

Food allergies, particularly to cow's milk and peanuts, are a big health concern, especially for children, where they can cause severe and even life-threatening reactions. It's a challenging situation for families, schools, and healthcare services. Currently, the main treatment is to avoid the trigger food, but accidental exposure is always a worry.

This study is exploring a treatment called oral immunotherapy (OIT). Think of it like a training program for your immune system. By carefully introducing tiny, increasing amounts of the food you're allergic to, the aim is to help your body become less sensitive. This way, if you accidentally eat the food, your reaction might be much milder, or you might not react at all. Importantly, this study is using foods that are commonly found in supermarkets, rather than specially prepared medical products, which could make the treatment more accessible and palatable.

Taking part in this study means you or your child would be closely monitored by medical professionals as you gradually increase your intake of the allergenic food. While there's a possibility of allergic reactions during this process, including severe ones, the team will prioritize your safety. Alongside seeing how well the treatment works and how safe it is, the study also wants to understand the long-term benefits and costs in the UK healthcare system, to help decide if this type of treatment should become more widely available.

Key takeaways

Study explores treating peanut and cow's milk allergy using everyday foods.
Aims to reduce severe allergic reactions through gradual exposure.
Open to young people aged 3-23 with specific types of allergies.
Treatment involves carefully eating small, increasing amounts of the allergen.
Safety is a priority, with close medical supervision for reactions.
Also looking at the long-term cost-effectiveness in the UK.

Who may be eligible?

The NATASHA study is looking for young people with certain food allergies. If you have a peanut allergy, you need to be between 6 and 23 years old. If you have a cow's milk allergy, you need to be between 3 and 23 years old. For both allergies, a doctor must have confirmed that you have a specific type of allergy called IgE-mediated, which means your body releases certain chemicals that cause allergic reactions.

To join, your allergy must not be extremely severe from the start; doctors will do a test to see how much of the allergen you can tolerate before treatment. If you're under 16, a parent or legal guardian needs to give permission, and if you're 6 or older, you'll also need to agree to take part.

There are some reasons why you might not be able to join. For example, if you've ever needed intensive care for an allergic reaction, or if you have other serious ongoing health conditions (apart from mild asthma, hay fever, or eczema). If your asthma is not well controlled, or your eczema is severe and requires strong treatments regularly, you might not be suitable. The study also can't include people with certain stomach conditions, those already on specific allergy treatments, or taking certain medications like beta-blockers or prebiotics/probiotics if you're unwilling to stop them.

Quick self-check

Are you between 6-23 years old with peanut allergy, or 3-23 years old with cow's milk allergy?
Has a doctor confirmed you have an IgE-mediated peanut or cow's milk allergy?
Have you not needed intensive care for an allergic reaction in the past?
Do you have well-controlled asthma, or is your asthma typically mild?
Are you generally healthy, without other serious long-term illnesses?
Are you able to get consent from a parent/guardian if under 16, and agree yourself if 6 or older?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in the NATASHA study, you will undergo a treatment plan where you gradually eat increasing amounts of the food you are allergic to (either peanut or cow's milk). This will be done very carefully, following a set plan, and always under the close supervision of medical staff. The study team will provide you with clear instructions on how to consume the food and what to do if you experience any symptoms.

Over time, you will have regular visits to the clinic so the doctors can check your progress and safety. They will monitor your reactions, adjust your food intake as needed, and carry out assessments to see how well the treatment is working. Throughout the study, you'll be giving information about your health and any allergic reactions you experience. The full duration of your participation in the study, including follow-up, will be explained in detail before you start, but it's designed to assess both short-term effectiveness and longer-term outcomes.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that successful oral immunotherapy could make you less sensitive to peanuts or cow's milk, potentially reducing the severity of accidental allergic reactions and improving your quality of life. However, a key risk is that allergic reactions, including severe ones (anaphylaxis), are common during this type of treatment. The study team will be experienced in managing these reactions, and your safety is their priority. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (5)

University of Hospitals of Leicester NHS Trust
Leicester, United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom
Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle, United Kingdom
Sheffield Children's Hospital NHS Foundation Trust
Sheffield, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom

Common questions

What is IgE-mediated allergy?

This is a common type of allergy where your body's immune system overreacts to a harmless substance (like peanut or milk), producing special antibodies called IgE that trigger allergic symptoms.

What is oral immunotherapy (OIT)?

OIT is a treatment where you gradually eat tiny, increasing amounts of the food you're allergic to, under medical supervision, to help your body become more tolerant and reduce allergic reactions.

Will I have to eat the food I'm allergic to?

Yes, as part of the treatment, you will be given specific, measured amounts of the food you are allergic to, starting with very small doses and gradually increasing them.

Is this a new treatment?

Oral immunotherapy is an emerging treatment. This study aims to understand its effectiveness and safety using everyday foods, and to collect long-term data for the UK healthcare system.

What if I can't stand the taste?

The study uses common foods, but it's understood that some allergic children dislike the taste. This is something the study is aware of and will consider for how treatment is given, but it might still be a challenge.