Status:
COMPLETED
Oesophageal Acid Exposure in Healthy Subjects Over 96 Hours
Lead Sponsor:
Guy's and St Thomas' NHS Foundation Trust
Conditions:
Gastroesophageal Reflux
Eligibility:
All Genders
18-65 years
Phase:
NA
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 ...
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 recruitm...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2019
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03417817
Start Date
October 16 2018
End Date
June 30 2019
Last Update
August 21 2019
Active Locations (2)
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1
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom, SE1 7EH
2
King's College London
London, United Kingdom, WC2R 2LS