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CompletedNCT07919522Updated Nov 5, 2026

The Prospective Observational Study Evaluating the Clinical Profile and Correlation of Subjective and Objective Parameters of GERD in a Tertiary Care Hospital : An Indian Perspective

An observational study in GERD, sponsored by Asian Institute of Gastroenterology, India. Completed at 1 site in India. Open to participants aged 18 Months to 50 Months. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by Asian Institute of Gastroenterology, India · Observational

Updated Nov 5, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Months to 50 Months
Sex
All
01

Study summary

This prospective, single-center study at AIG Hospitals, Hyderabad, aims to establish normal 24-hour ambulatory esophageal pH-impedance values, including acid exposure time (AET), in 50 healthy Indian adults. Current Western diagnostic cut-offs may not be applicable to the Indian population, where normal AET is likely lower. Healthy volunteers aged 18-50 with no GI symptoms or systemic diseases will undergo baseline evaluations, high-resolution manometry, and 24-hour pH-impedance monitoring while maintaining regular activities. The study will assess how diet, body position, and sleep affect reflux, with statistical analysis to determine normative values for improved GERD diagnosis in India.

02

Conditions studied

  • GERD
03

In context

Gastroesophageal Reflux

1,211 studies on the registry are indexed under Gastroesophageal Reflux; 202 are open to participants now.

This study's enrollment of 50 is below the median of 178 across 348 observational studies indexed under Gastroesophageal Reflux.

Browse Gastroesophageal Reflux studies →

Lead sponsor

Asian Institute of Gastroenterology, India is the lead sponsor of 135 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Months to 50 Months
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

This study will include adults aged 18-50 years with GERD symptoms

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Age ≥18 years.

Symptoms of GERD (heartburn, regurgitation, chest pain) diagnosed using:

Clinical symptoms based on validated questionnaires. Endoscopic findings (e.g., esophagitis, Barrett's esophagus). Provide written .

Exclusion criteria

Exclusion Criteria:

Pregnant women or breast-feeding women

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (actual)
Patient registry
No

Groups and cohorts

  • This study will include a cohort of adults aged 18-50 years with GERD symptoms
06

What researchers measure

Primary outcomes

  1. To correlate the subjective (GERD HRQL scores) and objective (Endoscopy, Esophageal manometry and 24-hour pH- impedance monitoring) parameters of GERD

    Time frame: 12 months

Secondary outcomes

  1. To develop predective models for forecasting manometric and pH findings

    Time frame: 12 months

07

Study locations

1 site
  • AIG hospitals
    Hyderabad, Telangana 500032, India
08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07919522
Responsible party
Mohan Ramchandani (Consultant Gastroenterologist, Asian Institute of Gastroenterology, India) — Principal investigator
First posted
Nov 5, 2026
Start date
Jan 1, 2026
Primary completion
Aug 1, 2026
Completion
Aug 8, 2026
Last update
Nov 5, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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