Oesophageal Acid Exposure in Healthy Subjects Over 96 Hours
Research type
Research Study
Full title
MEASUREMENT OF ACID EXPOSURE IN HEALTHY SUBJECTS USING 96 HOURS WIRELESS PH MONITORING (BRAVO)
IRAS ID
227671
Contact name
Terry Wong
Contact email
Sponsor organisation
Nottingham University Hospitals NHS Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 8 months, days
Research summary
First introduced over 40 years ago, the 24-hour catheter based pH studies have previously been found to be the gold standard in the diagnosis of gastro-oesophageal reflux disease (GORD). In 2003, the Bravo has revolutionised the study of GORD, allowing patients an improved comfort and ability to perform activities of daily living.
The back flow of gastric acid (acid exposure) in the oesophagus is monitored by a tiny pH sensor located in a capsule which is pinned temporarily to the wall of the oesophagus at the time of endoscopy. Normal measurements for acid exposure are established for 48-hour studies. However, our studies have shown that extending the duration of recording to 96 hours further improved the diagnostic yield for GORD in patients with negative 24-hour catheter-based tests
This study aims to determine the normal values for oesophageal acid exposure in healthy subjects, using the wireless pH monitoring over 96 hours. Participants of different age and sex ranges will include healthy volunteers and people referred for gastroscopy in context of other conditions (e.g. iron deficiency anaemia and suspected coeliac disease).
We anticipate the recruitment of 25 subjects over 6 months. Eligible candidates will be invited to attend an interview where they will be assessed for reflux symptoms using the Montreal GORD consensus definition and dysphagia based on the Hospital Odynophagia Dysphagia Questionnaire. A trained endoscopist will perform the Bravo™ capsule placement under conscious sedation then subjects will undergo 96-hour pH monitoring. Participants will be offered a questionnaire on their satisfaction with the overall study, discomfort and interference with activities of daily living.
Data analysis will include the standard components of oesophageal pH monitoring – acid exposure, number and duration of reflux episodes over 96 hours and 72 hours. The end of the study is when the last participant attends for his/her final hospital visit.
REC name
London - Surrey Research Ethics Committee
REC reference
18/LO/1467
Date of REC Opinion
15 Oct 2018
REC opinion
Further Information Favourable Opinion