NCT06928350

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2025

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 15, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

June 11, 2025

Status Verified

April 1, 2025

Enrollment Period

1.1 years

First QC Date

April 8, 2025

Last Update Submit

June 6, 2025

Conditions

GERD (Gastroesophageal Reflux Disease)

Keywords

24- hour pH impedance monitoringGERDAcid exposureHealthy volunteersIndian cohortreflux episodes

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

Study Arms (1)

A group of 50 healthy volunteers

A sample size of 50 healthy volunteers will be enrolled

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

50 Healthy participants

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AIG hospitals

Hyderabad, Telangana, 500082, India

RECRUITING

Related Publications (4)

  • Kim SY, Jung HK, Lee HA. Normal acid exposure time in esophageal pH monitoring in Asian and Western populations: A systematic review and meta-analysis. Neurogastroenterol Motil. 2021 Apr;33(4):e14029. doi: 10.1111/nmo.14029. Epub 2020 Dec 30.

    PMID: 33377596RESULT

  • Ramu B, Mohan P, Rajasekaran MS, Jayanthi V. Prevalence and risk factors for gastroesophageal reflux in pregnancy. Indian J Gastroenterol. 2011 May;30(3):144-7. doi: 10.1007/s12664-010-0067-3. Epub 2010 Dec 2.

    PMID: 21125366RESULT

  • Zhang D, Liu S, Li Z, Wang R. Global, regional and national burden of gastroesophageal reflux disease, 1990-2019: update from the GBD 2019 study. Ann Med. 2022 Dec;54(1):1372-1384. doi: 10.1080/07853890.2022.2074535.

    PMID: 35579516RESULT

  • El-Serag HB, Sweet S, Winchester CC, Dent J. Update on the epidemiology of gastro-oesophageal reflux disease: a systematic review. Gut. 2014 Jun;63(6):871-80. doi: 10.1136/gutjnl-2012-304269. Epub 2013 Jul 13.

    PMID: 23853213RESULT

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Central Study Contacts

Krithi Krishna Doctor

CONTACT

+91 9870083545drkrithivk@gmail.com

Musfira Kauser

CONTACT

+91 8919498067

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2025

First Posted

April 15, 2025

Study Start

April 1, 2025

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

June 11, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)