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

NCT ID: NCT01566383

Last Updated: 2017-02-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2013-08-27

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.

Conditions

Identify Normal MII-pH Parameters

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

24-hr pH monitoring

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 33 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Michael Vaezi

Medical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael F Vaezi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

120288

Identifier Type: -

Identifier Source: org_study_id