Assessing Normal Multichannel Intraluminal Impedance (MII)-pH Parameters for Today's Population
This trial has been terminated.
|Condition||identify normal mii-ph parameters|
|Treatment||24-hr ph monitoring|
|Sponsor||Vanderbilt University Medical Center|
|Start date||March 2012|
|End date||August 2013|
|Trial size||19 participants|
|Trial identifier||NCT01566383, 120288|
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.
|Intervention model||single group assignment|
Identify normal esophageal MII-pH parameter ranges in healthy volunteers
time frame: Following 24-hr pH monitoring
All participants from 33 years up to 65 years old.
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.
|Official title||Assessing Normal Multichannel Intraluminal Impedance (MII)-pH Parameters for Today's Population|
|Principal investigator||Michael F Vaezi, MD, PhD|
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