The Effect of High PCO2 Solution on Esophageal Acid Sensation (PC02)

July 20, 2010 updated by: Southern Arizona VA Health Care System

The Effect of High PCO2 Solution on Esophageal Acid Sensation in Healthy Patients Versus Those With Non-Erosive Reflux Disease.

To determine the effect of intraesophageal high PCO2 solution as compared to acidic and saline solutions on subjects' heartburn sensation using stiumlus-response functions.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Presently, the exact mechanism of GERD and the role of CO2 in pathogenesis of heartburn symptoms is unclear. CO2 conversion to protons may play a key role in the mechanism for heartburn sensation. This is a prospective, randomized study that will help further explore the mechanism for heartburn sensation in GERD patients and can be a prelude for further studies examining the role of new class antireflux agents such as carbonic anhydrase inhibitors in the treatment of patients with heartburn.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85723
        • Recruiting
        • Southern Arizona VA Health Care System
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ronnie Fass, M.D.
      • Tucson, Arizona, United States, 85723
        • Recruiting
        • Southern Arizona Veterans Health Care System
        • Contact:
        • Contact:
        • Principal Investigator:
          • RONNIE FASS, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

10 Healthy Controls

  • Normal EGD, Normal 24-hr pH
  • 18-80 Years of age
  • Able to read, understand and complete study questionnaires and diary
  • Able to understand study procedures and sign informed consent

  • Albe to comply with all study requirements

    10 NERD (Non-Erosive Reflux Disease)

  • 18-80 Years of age
  • Willing to stop PPI/H2 Blocker prior to EGD
  • Have heartburn symptoms 2+ times per week for at least 3 months.

Exclusion Criteria:

  • Esophageal erosions, Barretts, or peptic stricture on EGD
  • Previous esophageal, gastric or duodenal surgery
  • underlying co-morbidities
  • Diabetes mellitus (requires insulin), scleroderms, or neuromuscular disorder
  • Upper airway symptoms
  • Tricyclic antidepressants, antispasmodics, selective serotonin receptor inhibitors, thiazides, bile acid-binding agents or prokinetics
  • Patients who cannot or are unwilling to sign ICF

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group - Healthy Subjects
Healthy volunteers with normal EGD.
Procedure: PCO2 Acid Perfusion and 0.1N HCI Perfusion
A small tube will be inserted through the nostril and into the esophagus. A mild CO2 solution or a mild saline solution will be administered for aprox. 10 minutes during which you will be asked questions regarding any symptoms you may experience.
Active Comparator: NERD Group
Subjects with NERD. Heartburn symp x2 wk for 3 months. Normal EGD and abnormal 24 hour pH.
Procedure: 24-Hr Esohpageal pH Monitoring
There will be a 24-hr pH monitoring procedure and two 10-minute infusions each one week apart consisting of high PCO2 solution and 0.1 N HCI solution.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Mechanism of GERD
Time Frame: NA There is no exact timeframe.
Presently the exact mechanism of GERD and the role of CO2 in pathogenesis of heartburn sysmptoms is unclear. We aim to compare the effect of intraesophageal high PCO2 solution with saline solution on heartburn sensation.
NA There is no exact timeframe.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southern Arizona VA Health Care System

Investigators

  • Principal Investigator: Ronnie Fass, MD, Southern Arizona Veterans Health Care System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Anticipated)

October 1, 2010

Study Completion (Anticipated)

November 1, 2010

Study Registration Dates

First Submitted

May 21, 2010

First Submitted That Met QC Criteria

May 21, 2010

First Posted (Estimate)

May 24, 2010

Study Record Updates

Last Update Posted (Estimate)

July 21, 2010

Last Update Submitted That Met QC Criteria

July 20, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • The Effect of PCO2 Solution

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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