Recruiting

High PCO2 Solution

Sponsor:

Southern Arizona VA Health Care System

Code:

NCT01128608

Conditions

Gastroesophageal Reflux Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

24-Hr Esohpageal pH Monitoring

PCO2 Acid Perfusion and 0.1N HCI Perfusion

Study Details

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.

Conditions

Gastroesophageal Reflux Disease

Study ID

NCT01128608

Start date

Sep, 2009

Status verified date

Apr, 2010

Completion date

Nov, 2010

Anticipated

Primary completion date

Oct, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: Control Group - Healthy Subjects

Healthy volunteers with normal EGD.

active comparator: NERD Group

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

Interventions

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.

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.

Primary outcome measure

  • The Mechanism of GERD [ Time Frame: NA There is no exact timeframe. ]

Central Contacts and Locations

Central contacts

Marcia Willis, CCRC

520-792-1450marcia.willis@va.gov

Locations

Southern Arizona VA Health Care System

Recruiting

Tucson, Arizona, United States, 85723

Contacts

Ronnie Fass, M.D.

520-792-1450ronnie.fass@va.gov

Marcia Willis, CCRC

792.1450marcia.willis@va.gov

Principal Investigator:

Ronnie Fass, M.D.

Southern Arizona Veterans Health Care System

Recruiting

Tucson, Arizona, United States, 85723

Contacts

Ronnie Fass, MD

520-792-1450ronnie.fass@va.gov

Marcia Willis, CCRC

520-792-1450marcia.willis@va.gov

Principal Investigator:

Ronnie Fass, MD

More Information

Sponsor

Southern Arizona VA Health Care System

Last update posted

Jul 21, 2010

Last verified

Apr, 2010

Keywords

  • GERD
  • Heartburn
  • Acid Reflux

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Southern Arizona VA Health Care System on 2010-07-21.