Oesophageal Acid Exposure in Healthy Subjects Over 96 Hours
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|ClinicalTrials.gov Identifier: NCT03417817|
Recruitment Status : Not yet recruiting
First Posted : January 31, 2018
Last Update Posted : January 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Gastroesophageal Reflux||Device: Bravo||Not Applicable|
This is a single centre, investigator-led study on healthy subjects to determine the normal values for oesophageal acid exposure using the wireless pH (potential of hydrogen) monitoring over 96 hours. The investigators anticipate the recruitment of 25 participants over 6 months. Bravo capacity is 16 procedures/week which is not fully utilised. Up to 2 research cases/week can be allocated to these "free" slots.
Healthy volunteers and people without reflux referred for gastroscopy in context of other conditions (e.g. iron deficiency anaemia, coeliac disease) will be recruited and 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. It will be stated that the participant is free to withdraw from the study at any time and with no obligation to give the reason for withdrawal.
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, paired nonparametric test to compare median data and t-test for averaged data. Considering a 20% of drop-out rate (participants who cannot complete the test or participants' data is not useful), the investigators will recruit 25 subjects to achieve a sample size of 20.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||healthy subjects|
|Masking:||None (Open Label)|
|Official Title:||Measurement of Acid Exposure in Healthy Subjects Using 96 Hours Wireless pH Monitoring (Bravo™)|
|Estimated Study Start Date :||March 15, 2018|
|Estimated Primary Completion Date :||September 15, 2018|
|Estimated Study Completion Date :||September 15, 2018|
Bravo wireless pH monitoring over 96 hours
wireless pH monitoring over 96 hours
- Acid exposure time in 4 days/96 hours [ Time Frame: 4 days ]
- 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 ]Acid exposure measured as percent total time pH < 4
- Percent Upright time pH < 4 for each 24-hour period [ Time Frame: 1 day ]Acid exposure measured as percent Upright time pH < 4
- Percent Supine time pH < 4 for each 24-hour period [ Time Frame: 1 day ]Acid exposure measured as percent Supine time pH < 4
- Number of reflux episodes for each 24-hour period [ Time Frame: 1 day ]Acid exposure measured as number of reflux episodes
- Number of reflux episodes ≥ 5 min for each 24-hour period [ Time Frame: 1 day ]Acid exposure measured as number of reflux episodes ≥ 5 min
- Longest reflux episode (minutes) for each 24-hour period [ Time Frame: 1 day ]Acid exposure measured as the longest reflux episode (minutes)
- Bravo "cut off" value for each 24-hour period [ Time Frame: 1 day ]Acid exposure measured as Bravo "cut off" value
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03417817
|Contact: Jennifer Boston||+44207188 firstname.lastname@example.org|
|Contact: Elizabeth Bruna||+44207188 email@example.com|
|Principal Investigator:||Terry Wong, MA MD||Consultant Gastroenterologist, Guy's and St Thomas' NHS Foundation Trust|