Oesophageal reflux Digestive System Gastro-oesophageal reflux disease
Conditions
Interventions
Gaviscon Advance® or Milk of Magnesia will be provided during 28-hour pH-impedance monitoring. The study takes 28 hours in total
a 4-hour ambulatory pH-impedance study followed by a 4-hour observation after a meal with the catheter in situ. The study terminates when the catheter is withdrawn. There will be no follow-up thereaft
Sponsors
Guy's and St Thomas' NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 65 years, either sex 2. History of reflux symptoms (heartburn, acid regurgitation, chest pain) requiring referral for oesophageal manometry and pH studies 3. Patients with chronic cough or dental problems are not excluded from the trial; however, typical reflux symptoms must be present also. This is because there is little evidence that reflux events are responsible for symptoms in this group 4. Provision of written, fully informed consent to undergo mechanistic study procedures
Exclusion criteria
Exclusion criteria: 1. Significant gastrointestinal symptoms or disease other than reflux 2. Large hiatus hernia (greater than 3 cm) 3. Severe reflux oesophagitis or Barrett's oesophagus on endoscopy (Los Angeles [LA] classification grade III - IV) 4. Previous upper gastrointestinal (GI) surgery or interventions such as oesophageal dilatations 5. Predominant symptoms of motility disorders, e.g. dysphagia 6. Presence of major oesophageal dysmotility on manometry, e.g. achalasia, diffuse spasm, aperistalsis (greater than 80% swallows) 7. Significant co-morbidity requiring ongoing treatment or investigation 8. Physical, neurological or psychiatric conditions preventing repeated visits to hospital or compliance with study procedures (e.g. physical impairment/reduced mobility) 9. Pregnancy or lactation at the time of enrolment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gaviscon Advance®: 1. Will not impair the sensitivity of pH-impedance monitoring in vitro or in vivo 2. Will suppress both non-acid and acid reflux (distal and proximal reflux events) assessed by pH-impedance over a 4-hour period after a standardised test meal and over 24-hours ambulatory monitoring 3. Reduces the presence of pepsin in expectorated saliva 4 hours after a test meal In both in vitro and in vivo studies the effects of 'Gaviscon Advance®' will be compared to another over-the-counter antacid (Milk of Magnesia) that does not exhibit raft-forming properties (a characteristic unique to Gaviscon Advance® in which a roof is formed above gastric contents thereby preventing reflux). This is measured as soon as the catheter is withdrawn and the information on the received is downloaded. It is part of the routine analysis performed by the proprietary software for pH-impedance. | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
United Kingdom
Outcome results
None listed