RecruitingNAINTERVENTIONAL

Mucosal IgE to Improve Diagnosis of Food Allergy and Food Hypersensitivity

This research wants to find better ways to accurately diagnose food allergies and food sensitivities. It's often hard to tell the difference because the symptoms, like tummy troubles, can be very similar to other digestive issues. The study involves looking at small samples from the gut, called biopsies, to check for specific markers that might indicate an allergy. They are particularly interested in a substance called IgE, which is linked to allergic reactions. Researchers will also compare these gut findings with blood test results. By doing this, they hope to identify clearer signs of food allergies and sensitivities, which could lead to quicker and more accurate diagnoses for many people, helping them avoid unnecessary strict diets.

At a glance

Status

Recruiting

Phase

Sponsor

University of Erlangen-Nürnberg Medical School

Enrolment target

115

Start

01 Feb 2022

Estimated completion

31 Jan 2025

Food Allergy Food Hypersensitivity

What is this study about?

Imagine you're feeling unwell after eating certain foods, and it's hard to pinpoint exactly what's causing it. This is a common problem for many people with food allergies or sensitivities. The symptoms, like stomach aches or feeling bloated, can be very similar to other tummy troubles, making it tricky for doctors to figure out what's really going on. This often means people go on very strict diets without truly knowing what food is causing their issues.

This study aims to make that diagnosis much clearer. Researchers believe that looking closely at the gut itself might reveal important clues that current blood tests or skin prick tests sometimes miss. They're particularly interested in measuring certain substances in the gut, like IgE, which plays a big role in allergic reactions. They also want to see how gut samples react to different food allergens in a lab setting.

By comparing what they find in the gut with other tests, the scientists hope to discover new and more accurate ways to identify food allergies and sensitivities. This could lead to a future where people get a correct diagnosis faster, helping them manage their health better and avoid unnecessary dietary restrictions.

Key takeaways

Aims to improve diagnosis of food allergies and sensitivities.
Compares gut samples with blood tests for better clues.
Uses small gut tissue samples, often from an endoscopy.
Hopes to identify clearer markers for these conditions.
Could lead to more accurate diagnoses in the future.
Focuses on understanding how the gut reacts to food.

Who may be eligible?

This study is looking for adults aged 18 and over, both men and women, who are suspected of having a food allergy or food sensitivity. This means you might have ongoing tummy troubles or other symptoms that doctors think could be related to food.

They are also looking for healthy volunteers. These are people who are already scheduled to have an endoscopy (a procedure where a thin, flexible tube with a camera is used to look inside your body) for other reasons, such as a family history of certain conditions or to rule out a stomach irritation.

However, if you are pregnant, you won't be able to take part in this study.

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 18 years old or older?
Do you suspect you have a food allergy or sensitivity, or are you having an endoscopy for other reasons?
Are you able to provide informed consent (agree to take part after understanding the study)?
Are you not currently pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to participate, the main part of your involvement will be providing a small tissue sample from your gut. This is usually collected during an endoscopy, which you might already be having for other health reasons. For those with suspected food allergies, this biopsy sampling would be specifically arranged for the study. Doctors will then analyse these samples to look for specific markers related to allergies and inflammation. You'll also likely have blood tests taken to compare with the gut samples. The team will also grow miniature gut models, called organoids, from your tissue samples in the lab to see how they react to food allergens. The study doesn't involve taking any new medications. The total duration of your active participation, mainly involving the sample collection, would be fairly short term, but the research team will explain the exact timeline relevant to your specific situation.

Potential risks and benefits

Participating in research can offer potential benefits, such as contributing valuable information that could help improve the diagnosis of food allergies for many people in the future. You might also gain a deeper understanding of your own condition, though the study is not designed to provide individual diagnoses. Potential risks typically involve those associated with the biopsy procedure, such as mild discomfort or a very small chance of bleeding, which will be carefully managed. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg
Verified postcode
Erlangen, Germany· Recruiting

Common questions

What exactly is a 'food hypersensitivity'?

Food hypersensitivity is a broad term that includes both true food allergies and other reactions to food that don't involve the immune system in the same way, like lactose intolerance. This study is looking at both.

Will this study tell me exactly what food I'm allergic to?

While the study aims to improve diagnosis, it's a research project designed to find new patterns and markers. It might not give you a direct diagnosis of your specific allergy, but the information learned could help others in the future.

What is an endoscopy and is it painful?

An endoscopy is a common procedure where a thin, flexible tube with a camera is guided down your throat to look at your digestive system. It's usually done under sedation, so you shouldn't feel pain, but you might feel a little discomfort.

What happens to the samples once they are taken?

The samples, like small pieces of your gut tissue and blood, will be carefully analysed in a lab. Researchers will look for specific substances and immune responses to understand food allergies better.

Do I have to change my diet for this study?

The study description doesn't mention specific dietary changes for participation. However, it's best to discuss this with the research team directly, as your current diet might be relevant to the information they collect.

How to find out more

Yurdagül Zopf, Prof

yurdaguel.zopf@uk-erlangen.de +4991318545218 Official trial record

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