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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A group of 50 healthy volunteers | A sample size of 50 healthy volunteers will be enrolled |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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50 Healthy participants
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Krithi Krishna Doctor | Contact | +91 9870083545 | drkrithivk@gmail.com | |
| Musfira Kauser | Contact | +91 8919498067 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AIG hospitals | Recruiting | Hyderabad | Telangana | 500082 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33377596 | Result | 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. | |
| 21125366 | Result | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 29, 2025 | Apr 4, 2025 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| 35579516 | Result | 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. |
| 23853213 | Result | 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. |
| D004066 | Digestive System Diseases |