Identify Normal MII-pH Parameters
Conditions
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.
Interventions
PROCEDURE24-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
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
33 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identify normal esophageal MII-pH parameter ranges in healthy volunteers | 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. |
Countries
United States
Outcome results
None listed