GERD and Anti-Reflux Therapy Between Able-bodied and SCI Individuals

Summary

Respiratory dysfunction, esophageal dysmotility, and a gastroesophageal reflux disease (GERD) have been demonstrated to be highly prevalent in persons with SCI. GERD has been linked to respiratory symptoms and conditions such as asthma, chronic cough, and an increased rate of respiratory infections in the general population. In persons with asthma, respiratory symptoms and dependency on asthma medications have been reduced by treatment with anti-reflux medication. Possible mechanisms have been proposed for this link, including the microaspiration of reflux materials, which may result in airway acidification and aspiration pneumonia, or the stimulation of the vagus nerve through acid-sensitive receptors in the esophagus with associated esophageal inflammation and reflex bronchoconstriction. Investigators propose to study the effects of anti-reflux therapy (proton pump inhibition) in persons with SCI on objective and subjective symptoms of respiratory function to determine the underlying mechanisms of airway inflammation due to GERD.

Conditions

• Gastro Esophageal Reflux Disorder

Interventions

DRUG

Omeprazole

Omeprazole is a commonly prescribed anti-reflux medication. If a SCI patient has GERD, they will be prescribed with 40mg omeprazole twice daily for two months

DEVICE

24 Hour pH Monitor

Monitors the acidity and levels of pH in the esophagus for 24hours and helps diagnose people with GERD

PROCEDURE

Pulmonary Function Examination

Assess pulmonary function such as lung volumes, spirometry, and max inspiration/expiration pressures.

PROCEDURE

Exhaled Nitric Oxide

Used to measure inflammation markers for airway resistance.

PROCEDURE

Exhaled Breath Concentrate (EBC)

EBC will be used to measure airway inflammation via specific markers, such as 8-isoprostane. This marker, if elevated, has been identified as an indicator for asthma inflammation.

PROCEDURE

Bernstein's Acid Clearance Test

Bernstein test is a clinical test for the diagnosis of chest pain in association with gastric acid exposure

PROCEDURE

Esophageal Motility

Esophageal Motility will be used to measure a subject's ability to swallow a bolus (i.e. saline solution) and record pressure changes throughout the esophagus during the swallow. This will also be used to identify anatomical landmarks, such as lower esophageal sphincter, which are necessary for proper placement of 24hr pH catheter.

Sponsors & Collaborators

• James J. Peters Veterans Affairs Medical Center

  lead FED

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-08-31

Primary Completion

2018-08-31

Countries

• United States

Study Locations