NCT03417817

Oesophageal Acid Exposure in Healthy Subjects Over 96 Hours

Completed NA Last updated 21 August 2019

What this trial tests

NA trial testing Bravo in Gastroesophageal Reflux in 50 participants. Completed in 30 June 2019.

Timeline

16 October 2018

Primary endpoint
30 June 2019

30 June 2019

Quick facts

Lead sponsor	Guy's and St Thomas' NHS Foundation Trust
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	50
Start date	16 October 2018
Primary completion	30 June 2019
Estimated completion	30 June 2019
Sites	2 locations across United Kingdom

Drugs / interventions tested

• Bravo

Conditions studied

• Gastroesophageal Reflux — all drugs for Gastroesophageal Reflux →

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Who can join

Adults 18 to 65, any sex, with Gastroesophageal Reflux. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 backflow 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, the investigators' 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

The 96-hour recording is the current standard of care, despite the lack of normal ranges for this duration of the recording. The basis for the diagnosis of GORD in 96-hours studies is based on the 48-hours normal controls. The objective of this study is to determine the normal values for oesophageal acid exposure using the wireless pH recording apparatus over 96 hours in asymptomatic healthy subjects with unrestricted activity and diet.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.