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

Primary Purpose

Gastroesophageal Reflux Disease

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
24-Hr Esohpageal pH Monitoring
PCO2 Acid Perfusion and 0.1N HCI Perfusion
Sponsored by
Southern Arizona VA Health Care System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastroesophageal Reflux Disease focused on measuring GERD, Heartburn, Acid Reflux

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Southern Arizona VA Health Care SystemRecruiting
  • Southern Arizona Veterans Health Care SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Control Group - Healthy Subjects

NERD Group

Arm Description

Healthy volunteers with normal EGD.

Subjects with NERD. Heartburn symp x2 wk for 3 months. Normal EGD and abnormal 24 hour pH.

Outcomes

Primary Outcome Measures

The Mechanism of GERD
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.

Secondary Outcome Measures

Full Information

First Posted
May 21, 2010
Last Updated
July 20, 2010
Sponsor
Southern Arizona VA Health Care System
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1. Study Identification

Unique Protocol Identification Number
NCT01128608
Brief Title
The Effect of High PCO2 Solution on Esophageal Acid Sensation
Acronym
PC02
Official Title
The Effect of High PCO2 Solution on Esophageal Acid Sensation in Healthy Patients Versus Those With Non-Erosive Reflux Disease.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
October 2010 (Anticipated)
Study Completion Date
November 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Southern Arizona VA Health Care System

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease
Keywords
GERD, Heartburn, Acid Reflux

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group - Healthy Subjects
Arm Type
Active Comparator
Arm Description
Healthy volunteers with normal EGD.
Arm Title
NERD Group
Arm Type
Active Comparator
Arm Description
Subjects with NERD. Heartburn symp x2 wk for 3 months. Normal EGD and abnormal 24 hour pH.
Intervention Type
Procedure
Intervention Name(s)
24-Hr Esohpageal pH Monitoring
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
PCO2 Acid Perfusion and 0.1N HCI Perfusion
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Mechanism of GERD
Description
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.
Time Frame
NA There is no exact timeframe.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marcia Willis, CCRC
Phone
520-792-1450
Ext
2032
Email
marcia.willis@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronnie Fass, MD
Organizational Affiliation
Southern Arizona Veterans Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern Arizona VA Health Care System
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronnie Fass, M.D.
Phone
520-792-1450
Ext
5139
Email
ronnie.fass@va.gov
First Name & Middle Initial & Last Name & Degree
Marcia Willis, CCRC
Phone
792.1450
Ext
2032
Email
marcia.willis@va.gov
First Name & Middle Initial & Last Name & Degree
Ronnie Fass, M.D.
Facility Name
Southern Arizona Veterans Health Care System
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronnie Fass, MD
Phone
520-792-1450
Ext
5139
Email
ronnie.fass@va.gov
First Name & Middle Initial & Last Name & Degree
Marcia Willis, CCRC
Phone
520-792-1450
Ext
2032
Email
marcia.willis@va.gov
First Name & Middle Initial & Last Name & Degree
Ronnie Fass, MD

12. IPD Sharing Statement

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The Effect of High PCO2 Solution on Esophageal Acid Sensation

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