SWALLeOeW
Research type
Research Study
Full title
A mixed methods feasibility study into the use of physiological assessment in eosinophilic oesophagitis (EoE)
IRAS ID
299013
Contact name
Chris Ward
Contact email
Sponsor organisation
Newcastle Joint Research Office
Clinicaltrials.gov Identifier
TBC, Study will be registered on ISRCTN
Duration of Study in the UK
2 years, 7 months, 26 days
Research summary
This study aims to improve understanding of symptoms in 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, 1/3 patients with EoE continue to have symptoms, making activities such as eating and staying nourished a challenge. EoE affects 10-40/100,000 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 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. Two tests will be used to study the oesophagus in sixty patients with EoE:
Manometry: measures how the muscles in the oesophagus squeeze and clear swallowed material during eating.
pH/impedance: 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 approximately 20 minutes. pH/impedance testing involves the person going home with the tube (2mm 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 qualitative approach will help understand the feasibility of assessing EoE differently in the NHS, making steps towards improving quality of life for those affected.REC name
London - Surrey Borders Research Ethics Committee
REC reference
22/PR/1086
Date of REC Opinion
8 Nov 2022
REC opinion
Further Information Favourable Opinion