Normal Values of Ambulatory 24-hour Oesophageal pH-impedance Monitoring in an Indian Cohort of Participants

NCT06928350 · tracked via the Priya Life Science India tracker

Sponsor

Asian Institute of Gastroenterology, India

Phase

Observational

Started

2025-04-01

Last updated

2025-06-11

Condition(s) studied

GERD (Gastroesophageal Reflux Disease)

Study summary

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

Sex

ALL

Min age

18 Years

Max age

50 Years

Healthy volunteers

Accepted

Inclusion Criteria: * Adult 18-50 years of age * No gastro-intestinal symptoms * No past GI or thoracic or spine surgery * Not on any medications * No history of recent alcohol intake (0 drinks in the past 1 month) * Non smoker * Normal BMI (18.5-22.9) Exclusion Criteria: * 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

Primary outcome measure(s)

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 monitorin
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.

Trial sites (1)

Facility	City	Region	Status
AIG hospitals	Hyderabad	Telangana	Recruiting

More Asian Institute of Gastroenterology, India trials in India

Personalized Education and Pain Response in Chronic Pancreatitis Starting soon

Artificial Intelligence-Guided Detection of Blood Vessels to Enhance Safety in Third-Space Endoscopic Procedures Recruiting

Vonoprazan Evaluation Compared to Standard Triple Therapy in Helicobacter Pylori eRadication Recruiting

Vonaprazan Versus Esomeprazole for Healing of LA Grade B or Higher Esophagitis After POEM Recruiting

A COMBINATION OF RECTAL INDOMETHACIN AND COLD WATER EXPOSURE OF THE AMPULLA AFTER ERCP IS SUPERIOR TO RECTAL INDOMETHACIN ALONE IN REDUCING THE INCIDENCE OF POST-ERCP PANCREATITIS -RCT Recruiting

Other trials for the same condition

Biological Optimization Versus Standard Care in Post-POEM Achalasia Patients (BIO-POEM) Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06928350 on ClinicalTrials.gov ↗ ← All trials in India