The Effect of High PCO2 Solution on Esophageal Acid Sensation

Gastroesophageal Reflux Disease Clinical Trial

— PC02  

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01128608
• Other study ID #: The Effect of PCO2 Solution
• Status: Unknown status
• Phase: N/A
• First received: May 21, 2010
• Last updated: July 20, 2010
• Start date: September 2009
• Est. completion date: November 2010

Study information

• Verified date: April 2010
• Source: Southern Arizona VA Health Care System
• Contact: Marcia Willis, CCRC
• Phone: 520-792-1450
• Email: marcia.willis[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 20
• Est. completion date: November 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Southern Arizona VA Health Care System	Tucson	Arizona
United States	Southern Arizona Veterans Health Care System	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Southern Arizona VA Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	NA There is no exact timeframe.