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

Identify Normal MII-pH Parameters Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01566383
• Other study ID #: 120288
• Status: Terminated
• Phase: N/A
• First received: March 26, 2012
• Last updated: February 21, 2017
• Start date: March 2012
• Est. completion date: August 27, 2013

Study information

• Verified date: February 2017
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: August 27, 2013
• Est. primary completion date: August 27, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 33 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Identify Normal MII-pH Parameters

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify normal esophageal MII-pH parameter ranges in healthy volunteers	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.	Following 24-hr pH monitoring