Are tests of oesophageal (food pipe) function useful and acceptable to patients with eosinophilic oesophagitis?

ISRCTN	ISRCTN17786884
DOI	https://doi.org/10.1186/ISRCTN17786884
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Integrated Research Application System (IRAS)	299013
Protocol serial number	IRAS 299013
Sponsor	Newcastle upon Tyne Hospitals NHS Foundation Trust
Funder	National Institute for Health and Care Research

Submission date: 08/09/2022
Registration date: 12/09/2022
Last edited: 31/10/2025

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Miss Catherine Sykes
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
Email	c.sykes1@newcastle.ac.uk

Study information

Primary study design	Observational
Study design	Dual-site exploratory mixed-method feasibility study comprising a serial diagnostic study with embedded qualitative design
Secondary study design	Cohort study
Study type	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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	-
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	28/02/2026

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	60
Total final enrolment	51
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

United Kingdom
England

Study participating centres

University Hospital of North Durham

University Hospital of Durham
Dryburn Hospital
North Road
Durham
DH1 5TW
United Kingdom

University College London Hospital

235 Euston Road
London
NW1 2BU
United Kingdom

Darlington Memorial Hospital

Hollyhurst Road
Darlington
DL3 6HX
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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?
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol file	version 1.1	05/10/2022	24/11/2022	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
Protocol file	version 1.4		31/10/2025	No	No
Protocol file	version 1.5		31/10/2025	No	No

Additional files

ISRCTN17786884_PROTOCOL_V1.1_05Oct22.pdf: Protocol file
ISRCTN17786884_PROTOCOL_V1.2.pdf: Protocol file
ISRCTN17786884_PROTOCOL_V1.3.pdf: Protocol file
ISRCTN17786884_PROTOCOL_V1.4.docx: Protocol file
ISRCTN17786884_PROTOCOL_V1.5.docx: Protocol file

Editorial Notes

31/10/2025: Protocols uploaded.
29/09/2025: Total final enrolment added.
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.