The Effect of High PCO2 Solution on Esophageal Acid Sensation

Not Applicable

• Conditions: Gastroesophageal Reflux Disease
• Interventions: Procedure: PCO2 Acid Perfusion and 0.1N HCI Perfusion; Procedure: 24-Hr Esohpageal pH Monitoring

• Registration Number: NCT01128608
• Lead Sponsor: Southern Arizona VA Health Care System

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.

Study Timeline

• Study Start: 2009-09
• Status Verified: 2010-04
• Study First Submitted: 2010-05-21
• Study First Submitted QC: 2010-05-21
• Study First Posted: 2010-05-24
• Last Update Submitted: 2010-07-20
• Last Update Posted: 2010-07-21
• Primary Completion: 2010-10
• Study Completion: 2010-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group - Healthy Subjects	PCO2 Acid Perfusion and 0.1N HCI Perfusion	Healthy volunteers with normal EGD.
NERD Group	24-Hr Esohpageal pH Monitoring	Subjects with NERD. Heartburn symp x2 wk for 3 months. Normal EGD and abnormal 24 hour pH.

Primary Outcome Measures

Name	Time	Method
The Mechanism of GERD	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.

Trial Locations

Locations (2)

Southern Arizona VA Health Care System; 🇺🇸 Tucson, Arizona, United States

Southern Arizona Veterans Health Care System; 🇺🇸 Tucson, Arizona, United States