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

This study is currently recruiting participants.
Verified July 2013 by Vanderbilt University
Sponsor:
Information provided by (Responsible Party):
Michael Vaezi, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01566383
First received: March 26, 2012
Last updated: July 11, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Identify Normal MII-pH Parameters
Procedure: 24-hr pH monitoring

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Assessing Normal Multichannel Intraluminal Impedance (MII)-pH Parameters for Today's Population

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Identify normal esophageal MII-pH parameter ranges in healthy volunteers [ Time Frame: Following 24-hr pH monitoring ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: March 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   33 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01566383

Contacts
Contact: Tina Higginbotham, MPA tina.higginbotham@vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Tina Higginbotham, MPA       tina.higginbotham@vanderbilt.edu   
Principal Investigator: Michael F Vaezi, MD, PhD         
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37212
Contact: Tina Higginbotham, MPA       tina.higginbotham@vanderbilt.edu   
Principal Investigator: Michael F Vaezi, MD, PhD         
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Michael F Vaezi, MD, PhD Vanderbilt University
  More Information

No publications provided

Responsible Party: Michael Vaezi, Medical Director, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01566383     History of Changes
Other Study ID Numbers: 120288
Study First Received: March 26, 2012
Last Updated: July 11, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 14, 2014