Investigating non-invasive measurement of reflux disease
Research type
Research Study
Full title
Investigation into the correlation between non-invasive and invasive assessment of reflux disease
IRAS ID
158259
Contact name
Peter Dettmar
Contact email
Sponsor organisation
Hull & East Yorkshire Hospitals NHS Trust
Research summary
Gastro-oesophageal reflux disease (GORD) is a common disorder characterised by excessive flow of stomach contents back up into the oesophagus, causing symptoms. Its symptoms include heartburn, regurgitation, belching, chest pain, difficulty swallowing, hoarseness, and chronic cough. Current diagnostic methods for GORD, including 24-hour pH study, are invasive and expensive, requiring specialist equipment and interpretation.
Acid contained in the refluxate is traditionally thought of as the causative agent of GORD symptoms. More recently, research has suggested that pepsin, an enzyme that breaks down protein, may also contribute to symptoms. Because pepsin is normally only found in the stomach, its presence in saliva suggests that reflux has occurred. We aim to investigate the use of a non-invasive test for salivary pepsin (the Peptest) as a measure of reflux at the time of patient symptoms.
Patients with reflux symptoms, who are referred for 24-hour pH-studies to GI Physiology, Castle Hill Hospital as part of routine care, will be recruited. Participants will be asked to collect three saliva samples during 24-hour pH-monitoring when they feel symptom of GORD. The samples will be returned to the clinic when the patient returns to have their 24-hour pH tube removed. Participants will be asked to fill in a short questionnaire about their experience.
Samples will be analysed for pepsin and the results related to the acidity (pH) in the oesophagus at the time of collection. Currently, diagnosis of GORD does not consider the role of weak-acid and non-acid changes in pH. This study will investigate these further.
This research hopes to benefit patients and the public by assessing the efficacy of a non-invasive diagnostic procedure in routine patient assessment. It may also begin to shed light on the role of weak acid/non-acid reflux in GORD, potentially opening avenues for new treatments for a common gastrointestinal disease.REC name
London - Camberwell St Giles Research Ethics Committee
REC reference
14/LO/1419
Date of REC Opinion
7 Aug 2014
REC opinion
Further Information Favourable Opinion