Esophagitis Clinical Trial
Official title:
Twenty Four Hour Ambulatory pH & Impedance Testing: Normative Data for Indian Population
GERD is common in Indian population and the normative data which is used to diagnose & manage GERD and its complications are based on western data which is not validated in the Indian population. Although normative data is available for commonly used twenty-four impedance-pH parameters, their global application has limitations, stemming from use of small healthy volunteer cohorts from few countries for normative data. At present, there is no normative data for twenty-four hours impedance-pH monitoring in Indian population. The aim of this study is to obtain a new set of normal values specific for the Indian population.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Healthy individual > 18 years of age - Not on any acid lowering drug from at least 7 days. Exclusion Criteria: - Thoracic or digestive foregut surgery, - Alcohol consumption >40 g/day, - Use of medications that alter intragastric acidity or oesophageal motility - History of diabetes mellitus, - Neurological disorders - Chronic gastrointestinal disease - Any subject with upper GI symptoms like pain, burning, belching, bloating, dysphagia & aerophagia |
Country | Name | City | State |
---|---|---|---|
India | AIG Hospitals | Hyderabad | Telangana |
Lead Sponsor | Collaborator |
---|---|
Asian Institute of Gastroenterology, India |
India,
Roman S, Gyawali CP, Savarino E, Yadlapati R, Zerbib F, Wu J, Vela M, Tutuian R, Tatum R, Sifrim D, Keller J, Fox M, Pandolfino JE, Bredenoord AJ; GERD consensus group. Ambulatory reflux monitoring for diagnosis of gastro-esophageal reflux disease: Update — View Citation
Shay S, Tutuian R, Sifrim D, Vela M, Wise J, Balaji N, Zhang X, Adhami T, Murray J, Peters J, Castell D. Twenty-four hour ambulatory simultaneous impedance and pH monitoring: a multicenter report of normal values from 60 healthy volunteers. Am J Gastroent — View Citation
Sifrim D, Roman S, Savarino E, Bor S, Bredenoord AJ, Castell D, Cicala M, de Bortoli N, Frazzoni M, Gonlachanvit S, Iwakiri K, Kawamura O, Krarup A, Lee YY, Soon Ngiu C, Ndebia E, Patcharatraku T, Pauwels A, Pérez de la Serna J, Ramos R, Remes-Troche JM, — View Citation
Zerbib F, des Varannes SB, Roman S, Pouderoux P, Artigue F, Chaput U, Mion F, Caillol F, Verin E, Bommelaer G, Ducrotté P, Galmiche JP, Sifrim D. Normal values and day-to-day variability of 24-h ambulatory oesophageal impedance-pH monitoring in a Belgian- — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Normative values for impedance-pH monitoring in healthy Indian population. | There is no normative data for impedance-pH monitoring specific to indian population. The study aims to generate a reference value for the same by enrolling healthy individuals. | six months |
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