Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2026-03-08 @ 5:55 AM
Study NCT ID:
NCT06928350
Status:
RECRUITING
Last Update Posted:
2025-06-11
First Post:
2025-04-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Normal Values of Ambulatory 24-hour Oesophageal pH-impedance Monitoring in an Indian Cohort of Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-01-29', 'size': 480410, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2025-04-04T03:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-06', 'studyFirstSubmitDate': '2025-04-08', 'studyFirstSubmitQcDate': '2025-04-08', 'lastUpdatePostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Normal values of ambulatory 24-hour oesophageal pH-impedance monitoring in an Indian cohort of healthy volunteers', 'timeFrame': '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', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['24- hour pH impedance monitoring', 'GERD', 'Acid exposure', 'Healthy volunteers', 'Indian cohort', 'reflux episodes'], 'conditions': ['GERD (Gastroesophageal Reflux Disease)']}, 'referencesModule': {'references': [{'pmid': '33377596', 'type': 'RESULT', 'citation': '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': '21125366', 'type': 'RESULT', 'citation': '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': '35579516', 'type': 'RESULT', 'citation': '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': '23853213', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '50 Healthy participants', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult 18-50 years of age\n* No gastro-intestinal symptoms\n* No past GI or thoracic or spine surgery\n* Not on any medications\n* No history of recent alcohol intake (0 drinks in the past 1 month)\n* Non smoker\n* Normal BMI (18.5-22.9)\n\nExclusion Criteria:\n\n* 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)\n* GERD symptoms/ functional dyspepsia\n* Pregnant women or breast-feeding women\n* Helicobacter pylori infection'}, 'identificationModule': {'nctId': 'NCT06928350', 'briefTitle': 'Normal Values of Ambulatory 24-hour Oesophageal pH-impedance Monitoring in an Indian Cohort of Participants', 'organization': {'class': 'OTHER', 'fullName': 'Asian Institute of Gastroenterology, India'}, 'officialTitle': 'Normal Values of Ambulatory 24-hour Oesophageal pH-impedance Monitoring in an Indian Cohort of Participants', 'orgStudyIdInfo': {'id': 'Oesophageal PH-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'A group of 50 healthy volunteers', 'description': 'A sample size of 50 healthy volunteers will be enrolled'}]}, 'contactsLocationsModule': {'locations': [{'zip': '500082', 'city': 'Hyderabad', 'state': 'Telangana', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'AIG hospitals', 'role': 'CONTACT', 'email': 'info@aighospitals.com', 'phone': '040 4244 4222'}, {'name': 'Koduri Krithi Krishna, MBBS, MD, DNB', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Aniruddha Pratap Singh, MBBS, MD, DM', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AIG hospitals', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}], 'centralContacts': [{'name': 'Krithi Krishna Doctor', 'role': 'CONTACT', 'email': 'drkrithivk@gmail.com', 'phone': '+91 9870083545'}, {'name': 'Musfira Kauser', 'role': 'CONTACT', 'phone': '+91 8919498067'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asian Institute of Gastroenterology, India', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}