Assessing Normal Multichannel Intraluminal Impedance (MII)-pH Parameters for Today's Population

The normal values of a Multichannel Intraluminal Impedance (MII)-pH study can vary between ages, gender, race and different values of body mass index (BMI). This fact can cause new modifications in the normal values such as making new scales for different age groups or BMI groups.

Our aim is to find the normal esophageal MII-pH parameter ranges in volunteers who never experienced reflux related symptoms and are in between the same ranges of age and BMI of our gastroesophageal reflux disease (GERD) patient population.

Study Overview

• Status: Terminated
• Conditions: Identify Normal MII-pH Parameters
• Intervention / Treatment: Procedure: 24-hr pH monitoring

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 33 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy male and female adults between the ages of 33-65
• BMI range of 23.9 - 38.9
• Ability to give consent to participate in study

Exclusion Criteria:

• History of extraesophageal reflux disease symptoms such as chronic or acute cough and/or throat clearing and /or non-cardiac chest pain.
• History of gastroesophageal reflux disease (GERD) such as heartburn and/or regurgitation.
• History of proton pump inhibitor (PPI) usage ten days prior to the procedure (MII-pH) or H2RA's two days prior to MII-pH and antacids usage on the procedure day.
• History of thoracic, gastric or esophageal surgery.
• Histories of Diabetes Mellitus, neurological disorders, gastrointestinal disease, taking medication that alter the intragastric acidity or esophageal motility.
• Pregnancy or nursing mothers.
• Alcohol consumption >40g/day, smoking >10cigarettes/day.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Healthy Volunteers; Healthy volunteers who are matched (age, weight, gender) to the general patient population undergoing manometry and pH monitoring for GERD will undergo the same procedures to determine pH levels in people without reflux symptoms as compared to pH levels in those patients who have been diagnosed with reflux.

Procedure: 24-hr pH monitoring; Visit 1 The following will be done: A medical history including review of your current drugs;; Collection of demographic information;; A manometry, before the 24-hour pH testing, to find the junction between the esophagus and stomach;; 24-hour pH testing will be done Visit 2 You will return to the clinic 24 hours after the visit 1 and the following will occur: The catheter will be removed from your nose; and; You will return the recording device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identify normal esophageal MII-pH parameter ranges in healthy volunteers	Our aim is to find the normal esophageal MII-pH parameter ranges in volunteers who never experienced reflux related symptoms and are in between the same ranges of age and BMI of our GERD patient population.	Following 24-hr pH monitoring

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Michael F Vaezi, MD, PhD, Vanderbilt University

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): August 27, 2013
• Study Completion (Actual): August 27, 2013

Study Registration Dates

• First Submitted: March 26, 2012
• First Submitted That Met QC Criteria: March 28, 2012
• First Posted (Estimate): March 29, 2012

Study Record Updates

• Last Update Posted (Actual): February 23, 2017
• Last Update Submitted That Met QC Criteria: February 21, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 120288

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No