Normal 24-hour esophageal pH‑impedance values in healthy Indian adults
Normal Values of Ambulatory 24-hour Oesophageal pH-impedance Monitoring in an Indian Cohort of Participants
This project will measure 24-hour esophageal pH‑impedance readings, including acid exposure time, in healthy Indian adults to see what normal values are.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Asian Institute of Gastroenterology, India Academic / other |
| Locations | 1 site (Hyderabad, Telangana) |
| Trial ID | NCT06928350 on ClinicalTrials.gov |
What this trial studies
This prospective, single-center protocol will recruit healthy Indian volunteers aged 18–50 and record 24-hour ambulatory esophageal pH‑impedance monitoring. Participants without gastrointestinal symptoms or major systemic disease and with normal BMI will undergo sensor placement and continuous monitoring while usual meals, body positions, and sleep are recorded. The study will quantify acid exposure time (AET) and reflux episodes and analyze how diet, posture, and nocturnal periods affect these measures. The goal is to define population-specific normative cut-offs to improve GERD diagnosis in the Indian context.
Who should consider this trial
Good fit: Healthy Indian adults aged 18–50 with no gastrointestinal symptoms, no major systemic disease, non-smokers, not on medications, normal BMI (18.5–22.9), and no recent alcohol use are ideal candidates.
Not a fit: People with active GERD symptoms, diagnosed systemic diseases, abnormal BMI, smokers, pregnant or breastfeeding women, or those with H. pylori infection are unlikely to gain direct benefit from participation.
Why it matters
Potential benefit: If successful, the results could make GERD testing more accurate in India by providing population-specific normal values and reducing misclassification.
How similar studies have performed: Normative 24-hour pH‑impedance datasets exist from Western and some Asian cohorts showing population differences, but Indian-specific normative data are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hyderabad, Telangana
- AIG hospitals — Hyderabad, Telangana, India (Recruiting)
Study contacts
- Study coordinator: Krithi Krishna Doctor
- Email: drkrithivk@gmail.com
- Phone: +91 9870083545
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.