Oesophageal Acid Exposure in Healthy Subjects Over 96 Hours

NCT03417817 | Completed

• 1 other identifier: 227671
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Acid exposure time in 4 days/96 hours

  4 days

Secondary Outcomes (8)

• Acid exposure time in 3 days/72 hours

  3 days

• Percent total time pH < 4 for each 24-hour period

  1 day

• Percent Upright time pH < 4 for each 24-hour period

  1 day

• Percent Supine time pH < 4 for each 24-hour period

  1 day

• Number of reflux episodes for each 24-hour period

  1 day

Study Arms (1)

Healthy subjects

OTHER

Bravo wireless pH monitoring over 96 hours

Device: Bravo

Interventions

Bravo DEVICE

wireless pH monitoring over 96 hours

Healthy subjects

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (2)

Guy's and St Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

Location

King's College London

London, WC2R 2LS, United Kingdom

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Terry Wong, MA MD

  Consultant Gastroenterologist, Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: healthy subjects and subjects referred for gastroscopy in context of other conditions

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: January 31, 2018
• Study Start: October 16, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: August 21, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)