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

March 26, 2012
July 11, 2013
March 2012
December 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01566383 on ClinicalTrials.gov Archive Site
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Assessing Normal Multichannel Intraluminal Impedance (MII)-pH Parameters for Today's Population
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.

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Interventional
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Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Identify Normal MII-pH Parameters
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
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.
Intervention: Procedure: 24-hr pH monitoring
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2013
December 2013   (final data collection date for primary outcome measure)

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.
Both
33 Years to 65 Years
Yes
Contact: Tina Higginbotham, MPA tina.higginbotham@vanderbilt.edu
United States
 
NCT01566383
120288
No
Michael Vaezi, Vanderbilt University
Vanderbilt University
Not Provided
Principal Investigator: Michael F Vaezi, MD, PhD Vanderbilt University
Vanderbilt University
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP