About this trial
This study aims to determine normal 24-hour pH-impedance monitoring values, including acid exposure time (AET), in healthy Indian adults. It will help improve GERD diagnosis in India by providing population-specific data. The study will also explore how diet, body position, and nighttime reflux affect acid exposure. Healthy volunteers aged 18 and above will be monitored for 24 hours.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adult 18-50 years of age
No gastro-intestinal symptoms
No past GI or thoracic or spine surgery
Not on any medications
Disqualifiers
Any diagnosed systemic or organ specific disease (liver/kidney/heart/neurological disease, DM/HTN/Thyroid disease/ connective tissue disorder/inflammatory bowel disease/ irritable bowel syndrome)
GERD symptoms/ functional dyspepsia
Pregnant women or breast-feeding women
Helicobacter pylori infection
Trial population
50 Healthy participants
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Normal values of ambulatory 24-hour oesophageal pH-impedance monitoring in an Indian cohort of healthy volunteers
The primary outcome measures include the percentage of time the esophageal pH is below 4 (acid exposure time) and the total number of reflux episodes detected by impedance monitoring in both proximal and distal channels, assessed over a 24-hour monitoring period.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.