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

Not Applicable

Terminated

• Conditions: Identify Normal MII-pH Parameters
• Interventions: Procedure: 24-hr pH monitoring

• Registration Number: NCT01566383
• Lead Sponsor: Vanderbilt University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-26
• Study First Submitted QC: 2012-03-28
• Study First Posted: 2012-03-29
• Primary Completion: 2013-08-27
• Study Completion: 2013-08-27
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-21
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy Volunteers	24-hr pH monitoring	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States