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

NCT01566383 | Terminated

• 1 other identifier: 120288
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Identify Normal MII-pH Parameters

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Healthy Volunteers

EXPERIMENTAL

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

Interventions

24-hr pH monitoring PROCEDURE

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

Healthy Volunteers

Eligibility Criteria

• Age: 33 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (2)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Study Officials

• Michael F Vaezi, MD, PhD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: March 26, 2012
• First Posted: March 29, 2012
• Study Start: March 1, 2012
• Primary Completion: August 27, 2013
• Study Completion: August 27, 2013
• Last Updated: February 23, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)