Gastroesophageal Reflux Clinical Trial
Official title:
Measurement of Acid Exposure in Healthy Subjects Using 96 Hours Wireless pH Monitoring (Bravo™)
NCT number | NCT03417817 |
Other study ID # | 227671 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 16, 2018 |
Est. completion date | June 30, 2019 |
Verified date | August 2019 |
Source | Guy's and St Thomas' NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | June 30, 2019 |
Est. primary completion date | June 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Asymptomatic in: - GORD according to the Montreal GORD consensus definition - Dysphagia using the Hospital Odynophagia Dysphagia Questionnaire (HODQ) scoring < 7 - People without reflux referred for gastroscopy in context of other conditions e.g. iron deficiency anaemia, coeliac disease. - Subjects must sign an informed consent Exclusion Criteria: - Gastro-oesophageal symptoms in accordance with Montreal criteria - Previous abdominal operations on GI tract - Antireflux treatments either prescribed or over the counter - BMI > 35 - History of hepatic diseases, oesophageal varices - History of ischemic heart disease, asthma - Anticoagulants - Allergies - Pregnancy - Any medical or non-medical condition that in the opinion of the research team will make the candidate unfit for this study e.g. drug abuse etc. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Guy's and St Thomas' NHS Foundation Trust | London | |
United Kingdom | King's College London | London |
Lead Sponsor | Collaborator |
---|---|
Guy's and St Thomas' NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Acid exposure time in 4 days/96 hours | 4 days | ||
Secondary | Acid exposure time in 3 days/72 hours | 3 days | ||
Secondary | Percent total time pH < 4 for each 24-hour period | Acid exposure measured as percent total time pH < 4 | 1 day | |
Secondary | Percent Upright time pH < 4 for each 24-hour period | Acid exposure measured as percent Upright time pH < 4 | 1 day | |
Secondary | Percent Supine time pH < 4 for each 24-hour period | Acid exposure measured as percent Supine time pH < 4 | 1 day | |
Secondary | Number of reflux episodes for each 24-hour period | Acid exposure measured as number of reflux episodes | 1 day | |
Secondary | Number of reflux episodes = 5 min for each 24-hour period | Acid exposure measured as number of reflux episodes = 5 min | 1 day | |
Secondary | Longest reflux episode (minutes) for each 24-hour period | Acid exposure measured as the longest reflux episode (minutes) | 1 day | |
Secondary | Bravo "cut off" value for each 24-hour period | Acid exposure measured as Bravo "cut off" value | 1 day |
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