RecruitingNAINTERVENTIONAL

Capsule Sponge Study in Eosinophilic Oesophagitis

This study investigates a new, simpler way to check how well treatment is working for adults with a condition called Eosinophilic Oesophagitis (EoE). EoE causes swallowing difficulties and is usually checked with a gastroscopy, where a camera is put down your throat. This can be unpleasant. This study is testing a 'capsule sponge', which is a pill you swallow that collects cells from your food pipe to see if your treatment is effectively reducing inflammation. We want to see if this new test can be a good alternative to gastroscopy in everyday care and if patients prefer it. It's for adults whose EoE treatment has recently changed or started, and who haven't had a recent check-up.

At a glance

Status

Recruiting

Phase

Sponsor

East and North Hertfordshire NHS Trust

Enrolment target

140

Start

31 Jul 2023

Estimated completion

31 Jul 2025

Eosinophilic Esophagitis

What is this study about?

Eosinophilic Oesophagitis, or EoE, is a condition where a certain type of white blood cell, called eosinophils, build up in the lining of your food pipe (oesophagus). This build-up can make it hard to swallow or feel like food is getting stuck. If left untreated, it can cause problems like scarring and narrowing of the food pipe over time, which can make swallowing even more difficult. To keep track of EoE, doctors usually need to check the food pipe regularly to see if the treatment is working and reducing the number of these cells. This checking is often done using a procedure called gastroscopy, where a thin, flexible tube with a camera is passed down your throat.

Gastroscopy can be uncomfortable, and with many people needing these checks, it can be expensive and take up a lot of hospital time. Because of things like the COVID-19 pandemic, many patients have had their gastoscopies delayed or cancelled. This means there's a need for a simpler, less invasive way to monitor EoE. That's where the 'capsule sponge' comes in. It's a small capsule on a string that you swallow. Once in your stomach, it expands into a sponge. When the nurse gently pulls it back up, it collects cells from your food pipe which can then be tested.

This study wants to find out if using this capsule sponge can be a good alternative to gastroscopy for checking how well your EoE treatment is working, particularly for those whose treatment has recently changed or started. We also want to see if patients find the capsule sponge a more pleasant experience than gastroscopy. By offering this as an option, the study hopes to make monitoring EoE easier and more convenient for patients, without compromising on important health checks.

Key takeaways

This study is for adults with diagnosed EoE whose treatment has changed.
It tests a 'capsule sponge' as a gentler way to check treatment progress.
The capsule sponge aims to be an alternative to uncomfortable gastroscopies.
Your experience and preferences are an important part of the study.
Results could lead to improved monitoring for EoE patients in the future.

Who may be eligible?

This study is for adults, aged 18 or older, who have already been diagnosed with Eosinophilic Oesophagitis (EoE) and whose treatment has recently changed or started.

However, there are some reasons why you might not be able to take part. For example, if you have severe narrowing or rings in your food pipe that would stop the gastroscopy tube from passing, or if you've previously had your food pipe stretched or operated on. You also can't take part if you've had a tear in your food pipe, have cancer in your food pipe or stomach, or have swollen veins in your food pipe (called varices).

Other reasons for not being able to join include if you've recently had food get stuck in your food pipe that needed hospital treatment, have certain stomach surgeries, are taking a blood thinner called Warfarin and your blood levels are very high, or if your doctor only suspects you have EoE but it hasn't been confirmed by a gastroscopy yet.

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?
Have you been diagnosed with Eosinophilic Oesophagitis (EoE)?
Has your EoE treatment recently changed or started?
Do you *not* have severe narrowing or rings in your food pipe?
Have you *not* had certain stomach surgeries or major food pipe problems?
Are you *not* currently taking high doses of the blood thinner Warfarin?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll first be contacted by a nurse who will check if the study is safe for you and if you meet the initial requirements. You'll need to fill out a short questionnaire about your symptoms for the two weeks leading up to your clinic visit and the capsule sponge procedure. On the day of your capsule sponge procedure, you'll answer another symptom questionnaire. After the capsule sponge, you'll also complete a satisfaction survey about your experience.

The main part of your involvement will be having the capsule sponge procedure. This involves swallowing a small capsule on a string. After about 7 minutes, a nurse will gently pull the string to retrieve the sponge, which will have collected cells from your food pipe. These cells will then be sent for testing. You'll then have a follow-up appointment at the clinic about 6-8 weeks after your capsule sponge procedure. During this follow-up, your doctor will discuss the results and any changes to your management will be noted. The total duration of your participation in the study, from your initial clinic visit to your follow-up, will be around 8-10 weeks.

Potential risks and benefits

Taking part in this study could potentially offer you the benefit of monitoring your EoE treatment with a less invasive procedure than a traditional gastroscopy, which many find more comfortable. It also contributes to research that could help improve care for future EoE patients. As with any medical procedure, there are minor risks, although the capsule sponge is generally considered safe. The nurse will discuss any potential discomfort or rare risks with you before the procedure. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

East and North Herts NHS Trust
Verified postcode
Stevenage, United Kingdom· Recruiting

Common questions

What is Eosinophilic Oesophagitis (EoE)?

It's a condition where a type of white blood cell builds up in your food pipe, making it hard to swallow.

What is a capsule sponge?

It's a small pill on a string you swallow. It expands into a sponge and collects cells from your food pipe when pulled out.

Why is this study important?

It aims to find a simpler and more comfortable way to check if EoE treatment is working, instead of using a gastroscopy.

Will I still need gastroscopies if I join?

This study is testing if the capsule sponge can be an alternative, but your doctor will advise you on what's best for your ongoing care.

How long does the capsule sponge procedure take?

The sponge is usually in for about 7 minutes before it's gently removed.

How to find out more

Toral Odedra

toral.odedra@nhs.net 01438 314333 Official trial record

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