Are tests of oesophageal (food pipe) function useful and acceptable to patients with eosinophilic oesophagitis?
| ISRCTN | ISRCTN17786884 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17786884 |
| IRAS number | 299013 |
| Secondary identifying numbers | IRAS 299013 |
- Submission date
- 08/09/2022
- Registration date
- 12/09/2022
- Last edited
- 17/01/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
This study aims to improve understanding of the symptoms of eosinophilic oesophagitis (EoE), an inflammatory condition of the oesophagus (food pipe). Tests will be used to see if the oesophagus is working properly and symptoms will be recorded, both before and after a course of treatment. This work will help understand why, despite treatment, a third of patients with EoE continue to have symptoms, making activities such as eating and staying nourished a challenge. EoE affects 10-40 per 100,000 people. This number is increasing, with EoE linked to allergies, triggered by environmental factors or foods. Symptoms include food sticking in the oesophagus. In serious cases, food needs removing during an emergency endoscopy/camera test. EoE is diagnosed if increased eosinophils (cells involved in allergic responses) are found in tissue samples taken during endoscopy. However, treatment currently only addresses whether eosinophils are controlled, not whether the oesophagus works properly.
Who can participate?
Patients aged 18 years or over at participating hospitals with a diagnosis of EoE
What does the study involve?
Two low-risk tests will be used to study the oesophagus in sixty adult patients with EoE. Manometry measures how the muscles in the oesophagus squeeze and clear swallowed
material during eating. pH/impedance testing monitors inflammation in the oesophagus. Participants will have each test both before and after receiving treatment. The study will not
influence treatment decisions or standard care. Both tests involve passing a thin tube through the nose into the oesophagus. Manometry takes about 20 minutes. pH/impedance testing involves the person going home with the tube (2 mm diameter) in place for 24 hours, with information recorded during quiet periods/sleep. Results will be studied to see how inflammation affects oesophagus muscle function, the passage of food and symptoms. 20 patients will be interviewed to explore how acceptable these tests are in monitoring EoE. This approach will help understand the feasibility of assessing EoE differently in the NHS, making steps towards improving quality of life for those affected.
What are the possible benefits and risks of participating?
Whilst individuals will not directly benefit from participation, major test results will be contextualised and therefore individuals may receive further information about their condition.
Where is the study run from?
Newcastle upon Tyne NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
April 2021 to May 2025
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK)
Who is the main contact?
Catherine Sykes, c.sykes1@newcastle.ac.uk
Contact information
Scientific
Clinical Measurement Service
Medical Physics Department
Royal Victoria Infirmary
Newcastle upon Tyne
NE1 4LP
United Kingdom
 ORCID ID |
0000-0002-8518-5184 |
|---|---|
| Phone | +44 (0)191 282 4493 |
| c.sykes1@newcastle.ac.uk |
Study information
| Study design | Dual-site exploratory mixed-method feasibility study comprising a serial diagnostic study with embedded qualitative design |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | A mixed methods feasibility study into the use of physiological assessment in eosinophilic oesophagitis |
| Study acronym | SWALLeOeW |
| Study objectives | Observational study to assess the use and acceptability of physiological investigations of oesophageal function in understanding symptoms in eosinophilic oesophagitis (EoE) and to assess the relationship between physiological parameters, symptom profiles and response to treatment. |
| Ethics approval(s) | Approved 19/10/2022, London - Surrey Borders Research Ethics Committee (Equinox House, City Link, Nottingham, NG2 4LA, UK; +44 (0)207 104 8104; surreyborders.rec@hra.nhs.uk), ref: 22/PR/1086 |
| Health condition(s) or problem(s) studied | Eosinophilic oesophagitis |
| Intervention | High-resolution manometry (HRM) testing forms the initial part of this serial diagnostic study, assessing oesophageal function during eating in patients with EoE. Comparison will be made to diagnostic gold standards (water swallows) and patient-reported outcome measures (PROMs), using validated questionnaires for benign oesophageal motility disorders. HRM will be repeated following a treatment episode to assess for motility changes following treatment administered as part of standard care. pH/impedance monitoring forms the second part of the study, evaluating the use of mucosal impedance measurements in monitoring EoE status before and after standard therapy, with patients undergoing tests directly following HRM. Mucosal impedance will be measured to assess its practicability as a marker of mucosal integrity during quiescent nocturnal periods. Finally, a qualitative approach, using semi-structured interviews, will be used to explore themes surrounding the acceptability of tests to monitor disease status in individuals with EoE. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | - |
| Primary outcome measure | 1. Recruitment rate, recorded as the number of eligible participants who consent to participate in the study during the 21-month recruitment period 2. Attrition rate, assessed using the number of consented participants who do not remain in the study until the end of follow-up, defined as completing physiological assessments on visit 1 (single day) and where new medication is initiated, repeat investigations 2-4 months following this |
| Secondary outcome measures | 1. Swallowing parameters measured whilst participants eat a solid test meal using high-resolution manometry at visit 1/baseline (before any new treatment is instigated as part of routine clinical care) and at 2-4 months after a new treatment is instigated as part of routine clinical care where applicable 2. Temporal relationship between symptoms and swallowing parameters measured using high-resolution manometry during the solid test meal consumption both at visit 1/baseline and 2-4 months after a new treatment is instigated as part of routine clinical care where applicable 3. Mean nocturnal baseline impedance of the oesophageal mucosa measured using 24-hour ambulatory pH/impedance testing at visit 1/baseline (before a new treatment is instigated as part of routine clinical care) and at 2-4 months after a new treatment is instigated as part of routine clinical care where applicable 4. Gastro-oesophageal reflux exposure measured using 24-hour ambulatory pH/impedance testing at visit 1/baseline (before a new treatment is instigated as part of routine clinical care) and 2-4 months after a new treatment is instigated as part of routine clinical care where applicable 5. Dysphagia, reflux symptoms and oesophageal hypervigilance and anxiety measured using the Brief Esophageal Dysphagia Questionnaire, Reflux Disease Questionnaire and the Esophageal Hypervigilance and Anxiety Scale respectively, at visit 1 and 2-4 months after a new treatment is initiated (where applicable) 6. Routine markers of eosinophilic oesophagitis (e.g. histology, endoscopic appearances) measured as part of routine care will be compared to study findings from closest visits, e.g. baseline endoscopy compared to baseline tests and follow-up endoscopy 2-4 months after treatment initiation compared to follow-up tests |
| Overall study start date | 01/04/2021 |
| Completion date | 28/02/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | 1. Patients from County Durham and Darlington NHS Foundation Trust (CDDFT) or University College London Hospitals (UCLH) 2. Aged 18 years or over 3. New diagnosis of eosinophilic oesophagitis (>15/high-powered field (hpf) or 0.3 mm² on oesophageal biopsy and index oesophageal symptoms 4. Known diagnosis of eosinophilic oesophagitis (current histological and symptom status documented but does not impact inclusion) |
| Key exclusion criteria | 1. <18 years old 2. Current involvement in a Clinical Trial of an Investigational Medicinal Product (CTIMP) for eosinophilic oesophagitis (EoE) 3. Eosinophilia as a result of other known causes (local or systemic) 4. Oesophageal stricture on oesophagogastric duodenoscopy 5. Previous upper GI surgery 6. Active oesophageal comorbidity including Barrett’s oesophagus, oesophageal varices, coagulation disorders 7. Significant nasopharyngeal pathology, preventing nasogastric intubation 8. Opiate use 9. Unable to provide informed consent 10. Limited verbal communication 11. Non English speaker |
| Date of first enrolment | 07/10/2022 |
| Date of final enrolment | 31/08/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Dryburn Hospital
North Road
Durham
DH1 5TW
United Kingdom
London
NW1 2BU
United Kingdom
Darlington
DL3 6HX
United Kingdom
Sponsor information
Hospital/treatment centre
Newcastle Joint Research Office
Level 1, Regent Point
Regent Farm Road
Gosforth
Newcastle upon Tyne
NE3 3HD
England
United Kingdom
| Phone | +44 (0)191 282 5789 |
|---|---|
| aaron.jackson@nhs.net | |
| Website | http://www.newcastle-hospitals.org.uk/ |
"ROR" |
https://ror.org/05p40t847 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/12/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Three publications planned in high-impact peer-reviewed journals. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon appropriate request at the end of the study period from Catherine Sykes (c.sykes1@newcastle.ac.uk). Written informed consent will be obtained for every participant regarding data use of this nature and any data shared would be anonymised prior to sharing. Data will be available for a minimum of 5 years. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1.1 | 05/10/2022 | 24/11/2022 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol file | version 1.2 | 31/01/2024 | 01/03/2024 | No | No |
| Protocol file | version 1.3 | 30/05/2024 | No | No |
Additional files
Editorial Notes
17/01/2025: The following changes were made to the study record:
1. The recruitment end date was changed from 31/05/2025 to 31/08/2025.
2. The intention to publish date was changed from 01/06/2025 to 01/12/2026.
30/05/2024: Protocol uploaded.
01/03/2024: Protocol uploaded.
02/03/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 07/06/2024 to 31/05/2025.
2. The overall trial end date was changed from 31/05/2025 to 28/02/2026.
24/11/2022: Protocol uploaded (not peer reviewed). Ethics approval details added.
19/10/2022: The recruitment start date was changed from 17/10/2022 to 07/10/2022.
12/09/2022: Trial's existence confirmed by the NIHR.
