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

This study has been terminated.
(unable to meet recruitment goals)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01566383
First Posted: March 29, 2012
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Michael Vaezi, Vanderbilt University Medical Center
  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: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessing Normal Multichannel Intraluminal Impedance (MII)-pH Parameters for Today's Population

Further study details as provided by Michael Vaezi, Vanderbilt University Medical Center:

Primary Outcome Measures:
  • Identify normal esophageal MII-pH parameter ranges in healthy volunteers [ Time Frame: Following 24-hr pH monitoring ]
    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.


Enrollment: 19
Study Start Date: March 2012
Study Completion Date: August 27, 2013
Primary Completion Date: August 27, 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   33 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01566383


Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
Principal Investigator: Michael F Vaezi, MD, PhD Vanderbilt University
  More Information

Responsible Party: Michael Vaezi, Medical Director, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT01566383     History of Changes
Other Study ID Numbers: 120288
First Submitted: March 26, 2012
First Posted: March 29, 2012
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No


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