Twenty Four Hour Ambulatory pH & Impedance Testing: Normative Data for Indian Population

NCT05004155 | Unknown DMC

• 1 other identifier: AIG/IEC-BH&R 11/03 2021-01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Esophageal Diseases; Esophagitis; Reflux Disease

Keywords

esophageal diseases; normative data; Reflux disease

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

24 hour pH & impedance monitoring DIAGNOSTIC_TEST

24 hour pH impedance monitoring will be done on healthy subjects so that normative data specific to indian population can be generated.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will enroll only healthy asymtomatic subjects, so that normative data can be generated.

You may qualify if:

• Healthy individual \> 18 years of age
• Not on any acid lowering drug from at least 7 days.

You may not qualify if:

• 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

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

AIG Hospitals

Hyderabad, Telangana, 500032, India

RECRUITING

Related Publications (4)

• 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, Perez de la Serna J, Ramos R, Remes-Troche JM, Ribolsi M, Sammon A, Simren M, Tack J, Tutuian R, Valdovinos M, Xiao Y, Zerbib F, Gyawali CP. Normal values and regional differences in oesophageal impedance-pH metrics: a consensus analysis of impedance-pH studies from around the world. Gut. 2020 Oct 9:gutjnl-2020-322627. doi: 10.1136/gutjnl-2020-322627. Online ahead of print.

  PMID: 33037054 RESULT

• 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 of the Porto consensus and recommendations from an international consensus group. Neurogastroenterol Motil. 2017 Oct;29(10):1-15. doi: 10.1111/nmo.13067. Epub 2017 Mar 31.

  PMID: 28370768 RESULT

• Zerbib F, des Varannes SB, Roman S, Pouderoux P, Artigue F, Chaput U, Mion F, Caillol F, Verin E, Bommelaer G, Ducrotte P, Galmiche JP, Sifrim D. Normal values and day-to-day variability of 24-h ambulatory oesophageal impedance-pH monitoring in a Belgian-French cohort of healthy subjects. Aliment Pharmacol Ther. 2005 Nov 15;22(10):1011-21. doi: 10.1111/j.1365-2036.2005.02677.x.

  PMID: 16268977 RESULT

• 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 Gastroenterol. 2004 Jun;99(6):1037-43. doi: 10.1111/j.1572-0241.2004.04172.x.

  PMID: 15180722 RESULT

MeSH Terms

Conditions

Esophageal Diseases; Esophagitis; Gastroesophageal Reflux

Interventions

Hydrogen-Ion Concentration

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Esophageal Motility Disorders; Deglutition Disorders

Intervention Hierarchy (Ancestors)

Chemical Phenomena

Study Officials

• Rakesh kalapala, MBBS, MD, DM

  Senior Consultant

  STUDY DIRECTOR

• Pradev Inavolu

  Consultant

  PRINCIPAL INVESTIGATOR

• Hardik Rughwani

  Consultant

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anirrudha P Singh, MBBS, MD, DM

CONTACT

9004093248; draniruddhapratapsingh@gmail.com

Neeraj Singla, MBBS, MD, DM

CONTACT

7888619216; dr.neerajsingla@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 13, 2021
• Study Start: June 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 3, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)