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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
Sponsor:
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

Brief Summary:
First introduced over 40 years ago, the 24-hour catheter-based pH studies have previously been found to be the gold standard for the diagnosis of acid reflux. In 2003, the Bravo™ pH wireless monitoring revolutionised the study of gastroesophageal reflux disease (GORD), allowing patients an improved comfort and ability to perform activities of daily living. Normal ranges 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 diagnostic yield and consistency in patients with negative 24-hour catheter-based studies. 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.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Device: Bravo Not Applicable

Detailed Description:

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:

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
Healthy subjects
Bravo wireless pH monitoring over 96 hours
Device: Bravo
wireless pH monitoring over 96 hours




Primary Outcome Measures :
  1. Acid exposure time in 4 days/96 hours [ Time Frame: 4 days ]

Secondary Outcome Measures :
  1. Acid exposure time in 3 days/72 hours [ Time Frame: 3 days ]
  2. Percent total time pH < 4 for each 24-hour period [ Time Frame: 1 day ]
    Acid exposure measured as percent total time pH < 4

  3. Percent Upright time pH < 4 for each 24-hour period [ Time Frame: 1 day ]
    Acid exposure measured as percent Upright time pH < 4

  4. Percent Supine time pH < 4 for each 24-hour period [ Time Frame: 1 day ]
    Acid exposure measured as percent Supine time pH < 4

  5. Number of reflux episodes for each 24-hour period [ Time Frame: 1 day ]
    Acid exposure measured as number of reflux episodes

  6. 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

  7. Longest reflux episode (minutes) for each 24-hour period [ Time Frame: 1 day ]
    Acid exposure measured as the longest reflux episode (minutes)

  8. Bravo "cut off" value for each 24-hour period [ Time Frame: 1 day ]
    Acid exposure measured as Bravo "cut off" value



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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


Contacts
Contact: Jennifer Boston +44207188 7188 r&d@gstt.nhs.uk
Contact: Elizabeth Bruna +44207188 7188 r&d@gstt.nhs.uk

Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
Investigators
Principal Investigator: Terry Wong, MA MD Consultant Gastroenterologist, Guy's and St Thomas' NHS Foundation Trust

Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03417817     History of Changes
Other Study ID Numbers: 227671
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases