GERD (Gastroesophageal Reflux Disease)NCT06928350
Normal Values of Ambulatory 24-hour Oesophageal pH-impedance Monitoring in an Indian Cohort of Participants
An observational study of GERD (Gastroesophageal Reflux Disease), run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- GERD (Gastroesophageal Reflux Disease)
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- 1 Apr 2025to 1 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 50 Healthy participants
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Musfira Kauser contact
India1 site, 1 recruiting
- Recruiting
AIG hospitals
Hyderabad, Telangana, 500082
AIG hospitals, 040 4244 4222, info@aighospitals.com
Koduri Krithi Krishna, MBBS, MD, DNB
About this study
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.
Read the detailed description
This prospective study aims to establish normal 24-hour ambulatory pH-impedance monitoring values, including acid exposure time (AET), in healthy Indian volunteers. With an estimated GERD prevalence of 8-10% in India, current diagnostic criteria, such as the Lyon Consensus cut-off of 6%, may not be suitable for the Indian population due to differences in AET. The study will investigate the normative values of AET in healthy individuals and examine how factors such as diet, body position, and nocturnal reflux influence acid exposure and reflux episodes. By determining these standard values, the study seeks to enhance the accuracy of GERD diagnosis in India and improve understanding of reflux patterns specific to the Indian population. Participants will be healthy adults aged 18 and above, without gastrointestinal symptoms or major systemic diseases. The study will be conducted as a single-centre, 24-hour monitoring protocol.
- Conditions
- GERD (Gastroesophageal Reflux Disease)
- Keywords
- 24- hour pH impedance monitoring, GERD, Acid exposure, Healthy volunteers, Indian cohort, reflux episodes
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A group of 50 healthy volunteers | A sample size of 50 healthy volunteers will be enrolled |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start1 Apr 2025
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for GERD (Gastroesophageal Reflux Disease)Studies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06928350
- Sponsor's protocol ID
- Oesophageal PH-01
- Status last verified
- Apr 2025
- First submitted
- 8 Apr 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33377596Ramu 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.
PubMed 21125366Zhang 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.
PubMed 35579516El-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.
PubMed 23853213
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normal Values of Ambulatory 24-hour Oesophageal pH-impedance Monitoring in an Indian Cohort of Participants
- ClinicalTrials.gov ID
- NCT06928350
- Acronym / sponsor ID
- Oesophageal PH-01
- Conditions
- GERD (Gastroesophageal Reflux Disease)
- Keywords
- 24- hour pH impedance monitoring, GERD, Acid exposure, Healthy volunteers, Indian cohort, reflux episodes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 15 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This prospective study aims to establish normal 24-hour ambulatory pH-impedance monitoring values, including acid exposure time (AET), in healthy Indian volunteers. With an estimated GERD prevalence of 8-10% in India, current diagnostic criteria, such as the Lyon Consensus cut-off of 6%, may not be suitable for the Indian population due to differences in AET. The study will investigate the normative values of AET in healthy individuals and examine how factors such as diet, body position, and nocturnal reflux influence acid exposure and reflux episodes. By determining these standard values, the study seeks to enhance the accuracy of GERD diagnosis in India and improve understanding of reflux patterns specific to the Indian population. Participants will be healthy adults aged 18 and above, without gastrointestinal symptoms or major systemic diseases. The study will be conducted as a single-centre, 24-hour monitoring protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A group of 50 healthy volunteers | – | –A sample size of 50 healthy volunteers will be enrolled |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 50 Healthy participants
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Normal values of ambulatory 24-hour oesophageal pH-impedance monitoring in an Indian cohort of healthy volunteers
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Results publication: PubMed 33377596Kim 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.
- Results publication: PubMed 21125366Ramu 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.
- Results publication: PubMed 35579516Zhang 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.
- Results publication: PubMed 23853213El-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.
- Individual participant dataSharing planned: No
Related trials for GERD (Gastroesophageal Reflux Disease)
RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Musfira Kauser contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of GERD (Gastroesophageal Reflux Disease), run by Asian Institute of Gastroenterology, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Krithi Krishna Doctor (+91 9870083545, drkrithivk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normal values of ambulatory 24-hour oesophageal pH-impedance monitoring in an Indian cohort of healthy volunteers (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06928350, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.