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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: James J. Peters Veterans Affairs Medical Center
• Treatments: Nitric Oxide; Omeprazole

Criteria

Inclusion Criteria:

• Subjects with Tetraplegia (Level of SCI C4-8);

• Subjects with High Paraplegia (Level of SCI T1-T7);

• Subjects with Low Paraplegia (Level of SCI T8 or below);

• Able-Bodied Subjects (non SCI)

• Duration of injury ≥ 1 year; and

• Chronological age between 18-75 years.

Exclusion Criteria:

• Smoking, active or history of smoking < 6 months;

• Any history of blast injuries to the chest;

• Active respiratory disease or recent (within 3 months) respiratory infections;

• Use of medications known to alter airway caliber (i.e. beta 2 agonists or anticholinergic agents);

• Use of Protein Pump Inhibitors < 8 weeks before testing;

• Use of H2 receptor blockers <8 weeks before testing;

• History of gastrectomy;

• History of esophageal malignancy and/or resection