The EOS Network's patient focus group is participating in an important research study by Cyted. The study aims to determine whether a simpler test called an EndoSign®, or a capsule sponge, can be used to take samples from the oesophagus to monitor Eosinophilic Oesophagitis disease instead of a biopsy.

A group of patients from our community and representatives from Guts UK are collaborating with researchers from Cyted on the protocol and supporting resources for the QuBIE study.

Patient participation in studies enables researchers to understand what are the most important outcomes for patients during the study and in the future. From beginning to end, this collaborative partnership will review all documents and discuss improvements - everything from practical issues in the trial set-up (locations, procedure, etc.) to clear written explanations for study participants. 

This study focuses on identifying quantitative biomarkers for Eosinophilic Oesophagitis (EoE) in non-endoscopic capsule sponge (also known as the 'sponge on a string test') cell samples. These biomarkers will be used to monitor treatment effectiveness.

What is an EndoSign® Device

A capsule and expanded sponge used in the EndoSign® devices,  Cyted.ai

The capsule sponge device called EndoSign® is a medical tool that looks like a small pill attached to a string. Patients swallow the capsule, which dissolves in the stomach after up to 7 minutes, releasing the sponge. A nurse then gently pulls on the string to remove the sponge, which collects a sample of the cells lining the oesophagus.

This method can help hospitals determine if a patient's EoE is active or well-controlled on medication based on previous studies.

A capsule sponge is a safe sampling procedure. Over the last two years, County Durham and Darlington NHS Foundation Trust have conducted more than a thousand such procedures to investigate other conditions.

This research aims to enhance the accuracy of the capsule sponge test for EoE patients. This will be done by discovering new biomarkers that can be easily measured from the sample. To achieve this, the researchers will compare the results of the capsule sponge, gastroscopy (if a patient has undergone the procedure), the current medication, and the patient's reported symptoms.

Biomarkers are characteristics that can be measured and analysed to gain insight into a person's health. There are various types of biomarkers, and in healthcare, they can be used to diagnose a disease or understand how it may progress in the future.

Examples of biomarkers include blood pressure, body temperature, blood sugar for diabetes, pregnancy screenings, and COVID-19 tests.

Why this research is vital for patients with Eosinophilic Oesophagitis

Eosinophilic Oesophagitis (EoE) is a chronic, allergic inflammatory disease of the oesophagus, the tube that connects the mouth to the stomach ("food pipe"). 

This condition occurs when a type of white blood cell, the eosinophil, builds up in the lining of the oesophagus in response to foods, allergens, or acid reflux, leading to inflammation. Symptoms can include difficulty swallowing, food impaction, chest pain, and heartburn. 

Regular monitoring of the treatment can be challenging as it requires endoscopies, which can be uncomfortable and expensive, and requires recovery if sedation is used. 

Patients can experience delays due to long waiting times, making it challenging while waiting for the procedure.

The exact cause of EoE is still being researched, and there is currently no cure, making ongoing management and monitoring crucial for those affected.

This research holds significant potential for improving the lives of individuals with EoE. Currently, monitoring requires invasive procedures like endoscopic biopsies, which can be uncomfortable and costly. The sponge on a string test offers a less invasive, more patient-friendly alternative. By validating and enhancing this method, the study aims to make EoE monitoring more accessible and less distressing for patients. Furthermore, identifying new biomarkers from the capsule sponge samples could lead to more tailored treatments, ultimately improving patient outcomes and quality of life.

Who is organising and funding the research?

The sponsor of this study is Cyted, a leading gastrointestinal health company that manufactures the capsule sponge test. Cyted is working in partnership with East and North Hertfordshire NHS Trust, Nottingham University Hospitals, and County Durham & Darlington Foundation Trust. Innovate UK has funded the project and has undergone an independent ethical review by the UK Research Ethics Committee (REC).

Read more about the research with Sarah Killcoyne

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