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

Southern Arizona VA Health Care System

Status: Unknown

Conditions: Gastroesophageal Reflux Disease

Treatments: Procedure: PCO2 Acid Perfusion and 0.1N HCI Perfusion; Procedure: 24-Hr Esohpageal pH Monitoring

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01128608

The Effect of PCO2 Solution

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Control Group - Healthy Subjects

Active Comparator group

Description:

Healthy volunteers with normal EGD.

Treatment:

Procedure: PCO2 Acid Perfusion and 0.1N HCI Perfusion

NERD Group

Active Comparator group

Description:

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

Treatment:

Procedure: 24-Hr Esohpageal pH Monitoring