The Effect of High PCO2 Solution on Esophageal Acid Sensation

NCT01128608 | Unknown

• 1 other identifier: The Effect of PCO2 Solution
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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

Keywords

GERD; Heartburn; Acid Reflux

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Control Group - Healthy Subjects

ACTIVE COMPARATOR

Healthy volunteers with normal EGD.

Procedure: PCO2 Acid Perfusion and 0.1N HCI Perfusion

NERD Group

ACTIVE COMPARATOR

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

Procedure: 24-Hr Esohpageal pH Monitoring

Interventions

24-Hr Esohpageal pH Monitoring PROCEDURE

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.

NERD Group

PCO2 Acid Perfusion and 0.1N HCI Perfusion PROCEDURE

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.

Control Group - Healthy Subjects

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy Controls
• Normal EGD, Normal 24-hr pH
• 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
• NERD (Non-Erosive Reflux Disease)
• Years of age
• Willing to stop PPI/H2 Blocker prior to EGD
• Have heartburn symptoms 2+ times per week for at least 3 months.

You may not qualify if:

• 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

Sponsors & Collaborators

• Southern Arizona VA Health Care System: lead

Study Sites (2)

Southern Arizona VA Health Care System

Tucson, Arizona, 85723, United States

RECRUITING

Southern Arizona Veterans Health Care System

Tucson, Arizona, 85723, United States

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux; Heartburn

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ronnie Fass, MD

  Southern Arizona Veterans Health Care System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcia Willis, CCRC

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: FED

Study Record Dates

• First Submitted: May 21, 2010
• First Posted: May 24, 2010
• Study Start: September 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: November 1, 2010
• Last Updated: July 21, 2010

Record last verified: 2010-04

Locations

US (2)