Developing new tests to monitor patients with eosinophilic oesophagitis using capsule sponge instead of endoscopy
| ISRCTN | ISRCTN14071734 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14071734 |
| IRAS number | 334862 |
| Secondary identifying numbers | IRAS 334862, CPMS 59420 |
- Submission date
- 08/02/2024
- Registration date
- 23/02/2024
- Last edited
- 28/02/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Eosinophilic oesophagitis (EoE) is a disease of the oesophagus (“food pipe”) affecting tens of thousands of adults and children across the UK. Related to asthma, allergies and other chronic inflammatory conditions, this disease has been on the rise in recent years. However, it can often take years and even several trips to A&E due to food getting stuck in the oesophagus before a diagnosis is made. Treatments are available, but not all patients respond to treatment and the only way to check response is an invasive endoscopy. Finding the right treatment can take multiple endoscopies in a single year, and even after one is found a patient may need endoscopies throughout their life. This study aims to improve patient care in EoE in two ways: by decreasing the need for endoscopy through the use of minimally-invasive capsule sponge testing to collect cells from the oesophagus, and by providing a personalised predictive test for therapy response.
Who can participate?
Patients over 18 years old with EoE
What does the study involve?
Participants are offered both an endoscopy and a capsule sponge test. The resulting information will be clinically validated diagnoses alongside biomarker measurements, providing a clear readout for personalised EoE management.
What are the possible benefits and risks of participating?
This study is to assess if a simpler test, known as capsule sponge, can be used to regularly manage EoE instead of endoscopy. The capsule sponge test is:
1. Quick, the procedure only lasts for 10 minutes
2. Less invasive and does not require any sedation
3. A more comfortable experience (as stated by other patients)
4. Well-tested, more than 17,000 tests have been given to patients with no serious side effects
Disadvantages of taking part:
1. Participants may experience a mild sore throat for up to 24 hours and in some people, this may last for a few days. Paracetamol and throat lozenges can be taken to help.
2. There is a very small risk (less than 1 in 2,000) of the sponge becoming detached from the thread, or the nurse is unable to remove it. If this happens, it will be easily removed during your endoscopy.
3. There is a very small risk that you may have some bleeding. If this happens, you will be assessed by your consultant and clinical nurse. This is unlikely to need any intervention but if required an endoscopy could be performed to find and stop the bleeding. This has never been needed in 10+ years of tests.
Where is the study run from?
Cyted Ltd (UK)
When is the study starting and how long is it expected to run for?
June 2023 to December 2025
Who is funding the study?
Innovate UK
Who is the main contact?
Samantha Roberts, samantha.roberts@cyted.ai
Contact information
Public
22 Station Road
Cambridge
CB1 2JD
United Kingdom
| Phone | +44 (0)1480 453 437 |
|---|---|
| samantha.roberts@cyted.ai |
Scientific, Principal Investigator
22 Station Road
Cambridge
CB1 2JD
United Kingdom
 ORCID ID |
0000-0003-3686-6167 |
|---|---|
| Phone | +44 (0)1480 453 437 |
| sarah.killcoyne@cyted.ai |
Study information
| Study design | Open-label parallel-arm cohort study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format please use contact details to request a participant information sheet |
| Scientific title | Quantitative biomarker identification for eosinophilic oesophagitis in non-endoscopic capsule sponge cell samples for monitoring treatment efficacy |
| Study acronym | QuBIE |
| Study objectives | It is hypothesised that non-endoscopic capsule-based sponge cell collection will enable the identification of quantitative biomarkers for accurately monitoring the activity of disease in treated eosinophilic oesophagitis (EoE) patients. |
| Ethics approval(s) |
Approved 01/02/2024, North West - Greater Manchester East Research Ethics Committee (3rd Floor, Barlow House, 4 Minshull Street, Manchester, M1 3DZ, United Kingdom; +44 (0)207 104 8290; gmeast.rec@hra.nhs.uk), ref: 23/NW/0384 |
| Health condition(s) or problem(s) studied | Eosinophilic oesophagitis (EoE) |
| Intervention | Patients will be asked to undergo a capsule sponge test prior to a standard endoscopy with biopsy |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Eosinophil count in biopsy vs sponge pathology (number of eosinophils per high power field - standard measures in diagnosis) at time of procedure and for the sub-group at follow-up 8-12 weeks later 2. Biomarker quantification using ELISA assays for selected biomarkers at time of procedure and for the sub-group at follow-up 8-12 weeks later 3. Severity of symptoms measured using the Dysphagia Symptom Questionnaire (DSQ) at time of procedure and for the sub-group at follow-up 8-12 weeks later |
| Secondary outcome measures | Patient satisfaction measured using survey at time of procedure and for the sub-group at follow-up 8-12 weeks later |
| Overall study start date | 02/06/2023 |
| Completion date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | Both |
| Target number of participants | 200 |
| Key inclusion criteria | 1. Over 18 years old with a histologically confirmed diagnosis of EoE 2. Male or Female 3. Newly diagnosed patients with EoE or known existing non-stenotic EoE patients who are on maintenance treatments (i.e., orodispersible budesonide, PPI, biologics, or dietary therapy) and monitoring 4. Patients currently enrolled in the CoSIE study (IRAS 314770) may be retrospectively included with consent |
| Key exclusion criteria | 1. Age <18 years 2. Strictures or severe rings at most recent endoscopy that prevent passage of adult 9.8 mm gastroscope 3. Oesophageal dilatation within 24 months of clinic visit 4. Previous oesophageal perforation or surgical resection 5. Oesophagogastric malignancy 6. Oesophageal varices 7. Bolus obstruction since last endoscopy requiring hospital visit 8. Previous fundoplication or complicated hiatus hernia 9. Patient on warfarin with INR>=3 |
| Date of first enrolment | 01/02/2024 |
| Date of final enrolment | 31/10/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Coreys Mill Lane
Stevenage
SG1 4AB
United Kingdom
Derby Road
Nottingham
NG7 2UH
United Kingdom
Hollyhurst Road
Darlington
DL3 6HX
United Kingdom
Sponsor information
Industry
22 Station Road
Cambridge
CB1 2JD
England
United Kingdom
| Phone | +44 (0)1480 453 437 |
|---|---|
| hello@cyted.ai | |
| Website | cyted.ai |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- innovateuk
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/01/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a clinical journal for gastroinestinal diseases upon completion of study. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
28/02/2025: The following changes were made:
1. The recruitment end date was changed from 31/10/2025 to 31/10/2025.
2. The overall study end date was changed from 01/06/2025 to 31/12/2025.
27/01/2025: The following changes were made:
1. The target number of participants was changed from 250 to 200.
2. The recruitment end date was changed from 04/01/2025 to 31/10/2025.
04/03/2024: Internal review.
16/02/2024: Study's existence confirmed by the North West - Greater Manchester East Research Ethics Committee.
