Gastroesophageal RefluxNCT03417817
Oesophageal Acid Exposure in Healthy Subjects Over 96 Hours
A study testing Bravo in people with Gastroesophageal Reflux, run by Guy's and St Thomas' NHS Foundation Trust at 2 sites in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroesophageal Reflux
- What is being tested?
- Bravo
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 16 Oct 2018to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Guy's and St Thomas' NHS Foundation Trust
London, SE1 7EH
King's College London
London, WC2R 2LS
About this study
Official title: Measurement of Acid Exposure in Healthy Subjects Using 96 Hours Wireless pH Monitoring (Bravo™)
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.
Read the detailed description
This is a single centre study on healthy subjects to determine the normal values for oesophageal acid exposure using the wireless pH monitoring over 96 hours. The investigators anticipate the recruitment of 50 participants over 10 months.
Subjects without reflux symptoms, either healthy volunteers (hospital staff and medical students) or people referred for gastroscopy in the context of other conditions (e.g. iron deficiency anaemia, suspected coeliac disease) will be recruited. An interview will be arranged where the subjects will be assessed for gastro-oesophageal symptoms using the Montreal GORD consensus definition and dysphagia based on the Hospital Odynophagia Dysphagia Questionnaire. Once confirmed asymptomatic, participants will be offered an appointment for enrolment. If candidates are asymptomatic, the subjects will be invited to a further interview where the procedure, risks and benefits will be discussed in detail. If participants fulfil the inclusion and exclusion criteria then participants will be given the option to enrol in the study. If at any point, participants wish to withdraw from the study, they have the option to do so without explaining why.
Once recruited the following assessments and interventions will take place:
- Endoscopy and Bravo capsule placement under conscious sedation. The procedure will be performed by a trained endoscopist in using Bravo delivery system and dealing with any complications that may arise. Photographic documentation of capsule attachment will be taken.
- 96-hour pH monitoring. Study subjects will be asked to document food intake, periods of sleep and occurrence of symptoms in a diary. After 96 hours, participants will return to the Oesophageal Laboratory to hand back in the receivers and diaries. The data captured on the recorder during the procedure will be downloaded to a computer.
- Subjects will be offered a questionnaire detailing participants satisfaction with the overall study and an assessment of discomfort and interference with activities of daily living (diet, activity level) using a 5-point grading scale (1 = very unhappy/intolerant, 5 = very satisfied). A yes/no evaluation of participants ability to go to work or study on the day following the procedure and whether the participants would recommend this test to another person is also included.
- 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.
- Statistical analysis will involve standard deviation, mean, median, 95th/5th percentiles and 25th/75th percentiles. Considering a 30% drop-out rate (the participants who cannot complete the test or their data is not useful), we will recruit 50 subjects to achieve 35
- Conditions
- Gastroesophageal Reflux
- Being tested
- Bravo
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BravoDevice
wireless pH monitoring over 96 hours
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Other | Bravo wireless pH monitoring over 96 hours Receives: Device: Bravo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acid exposure time in 4 days/96 hours
Measured: 4 days
Secondary outcomes (8)
Acid exposure time in 3 days/72 hours
Measured: 3 days
Percent total time pH < 4 for each 24-hour period
Acid exposure measured as percent total time pH < 4
Measured: 1 day
Percent Upright time pH < 4 for each 24-hour period
Acid exposure measured as percent Upright time pH < 4
Measured: 1 day
Percent Supine time pH < 4 for each 24-hour period
Acid exposure measured as percent Supine time pH < 4
Measured: 1 day
Number of reflux episodes for each 24-hour period
Acid exposure measured as number of reflux episodes
Measured: 1 day
Number of reflux episodes ≥ 5 min for each 24-hour period
Acid exposure measured as number of reflux episodes ≥ 5 min
Measured: 1 day
Longest reflux episode (minutes) for each 24-hour period
Acid exposure measured as the longest reflux episode (minutes)
Measured: 1 day
Bravo "cut off" value for each 24-hour period
Acid exposure measured as Bravo "cut off" value
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start16 Oct 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- healthy subjects and subjects referred for gastroscopy in context of other conditions
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Terry Wong, MA MD, Principal investigator, Consultant Gastroenterologist, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03417817
- Sponsor's protocol ID
- 227671
- Status last verified
- Aug 2019
- First submitted
- 8 Jan 2018
- Last updated
- 21 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Acid Exposure in Healthy Subjects Using 96 Hours Wireless pH Monitoring (Bravo™)
- ClinicalTrials.gov ID
- NCT03417817
- Acronym / sponsor ID
- 227671
- Conditions
- Gastroesophageal Reflux
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 31 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a single centre study on healthy subjects to determine the normal values for oesophageal acid exposure using the wireless pH monitoring over 96 hours. The investigators anticipate the recruitment of 50 participants over 10 months.
Subjects without reflux symptoms, either healthy volunteers (hospital staff and medical students) or people referred for gastroscopy in the context of other conditions (e.g. iron deficiency anaemia, suspected coeliac disease) will be recruited. An interview will be arranged where the subjects will be assessed for gastro-oesophageal symptoms using the Montreal GORD consensus definition and dysphagia based on the Hospital Odynophagia Dysphagia Questionnaire. Once confirmed asymptomatic, participants will be offered an appointment for enrolment. If candidates are asymptomatic, the subjects will be invited to a further interview where the procedure, risks and benefits will be discussed in detail. If participants fulfil the inclusion and exclusion criteria then participants will be given the option to enrol in the study. If at any point, participants wish to withdraw from the study, they have the option to do so without explaining why.
Once recruited the following assessments and interventions will take place:
- Endoscopy and Bravo capsule placement under conscious sedation. The procedure will be performed by a trained endoscopist in using Bravo delivery system and dealing with any complications that may arise. Photographic documentation of capsule attachment will be taken.
- 96-hour pH monitoring. Study subjects will be asked to document food intake, periods of sleep and occurrence of symptoms in a diary. After 96 hours, participants will return to the Oesophageal Laboratory to hand back in the receivers and diaries. The data captured on the recorder during the procedure will be downloaded to a computer.
- Subjects will be offered a questionnaire detailing participants satisfaction with the overall study and an assessment of discomfort and interference with activities of daily living (diet, activity level) using a 5-point grading scale (1 = very unhappy/intolerant, 5 = very satisfied). A yes/no evaluation of participants ability to go to work or study on the day following the procedure and whether the participants would recommend this test to another person is also included.
- 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.
- Statistical analysis will involve standard deviation, mean, median, 95th/5th percentiles and 25th/75th percentiles. Considering a 30% drop-out rate (the participants who cannot complete the test or their data is not useful), we will recruit 50 subjects to achieve 35
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- healthy subjects and subjects referred for gastroscopy in context of other conditions
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | Other | Device: BravoBravo wireless pH monitoring over 96 hours |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Asymptomatic in:
- People without reflux referred for gastroscopy in context of other conditions e.g. iron deficiency anaemia, coeliac disease.
- Subjects must sign an informed consent
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bravowireless pH monitoring over 96 hours | Device | Healthy subjects |
Primary outcome
Acid exposure time in 4 days/96 hours
Time frame: 4 days
8 secondary outcomes
Acid exposure time in 3 days/72 hours
Time frame: 3 days
Percent total time pH < 4 for each 24-hour period
Time frame: 1 day
Percent Upright time pH < 4 for each 24-hour period
Time frame: 1 day
Percent Supine time pH < 4 for each 24-hour period
Time frame: 1 day
Number of reflux episodes for each 24-hour period
Time frame: 1 day
Number of reflux episodes ≥ 5 min for each 24-hour period
Time frame: 1 day
Longest reflux episode (minutes) for each 24-hour period
Time frame: 1 day
Bravo "cut off" value for each 24-hour period
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
- Individual participant dataSharing planned: No
Related trials for Gastroesophageal Reflux
RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terry Wong, MA MD principal investigator
Consultant Gastroenterologist, Guy's and St Thomas' NHS Foundation Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bravo in people with Gastroesophageal Reflux, run by Guy's and St Thomas' NHS Foundation Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acid exposure time in 4 days/96 hours (time frame: 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2019.