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

Vanderbilt University Medical Center

Status: Terminated

Conditions: Identify Normal MII-pH Parameters

Treatments: Procedure: 24-hr pH monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT01566383

120288

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 33 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

19 participants in 1 patient group

Healthy Volunteers

Experimental group

Description:

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.

Treatment:

Procedure: 24-hr pH monitoring