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Oesophageal Acid Exposure in Healthy Subjects Over 96 Hours

NCT03417817 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-08-21

No results posted yet for this study

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 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.

Conditions

  • Gastroesophageal Reflux

Interventions

DEVICE

Bravo

wireless pH monitoring over 96 hours

Sponsors & Collaborators

  • Guy's and St Thomas' NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Terry Wong, MA MD · Consultant Gastroenterologist, Guy's and St Thomas' NHS Foundation Trust

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-16
Primary Completion
2019-06-30
Completion
2019-06-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03417817 on ClinicalTrials.gov