Overview

This trial is active, not recruiting.

Condition identify normal mii-ph parameters
Treatment 24-hr ph monitoring
Sponsor Vanderbilt University
Start date March 2012
End date December 2016
Trial size 50 participants
Trial identifier NCT01566383, 120288

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
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.
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

Primary Outcomes

Measure
Identify normal esophageal MII-pH parameter ranges in healthy volunteers
time frame: Following 24-hr pH monitoring

Eligibility Criteria

Male or female 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.

Additional Information

Official title Assessing Normal Multichannel Intraluminal Impedance (MII)-pH Parameters for Today's Population
Principal investigator Michael F Vaezi, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Vanderbilt University.