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

Status unconfirmed · Phase 1

Conditions studied: Gastro Esophageal Reflux Disorder

In brief

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.

Key facts

Study ID

NCT02584751

Run by

James J. Peters Veterans Affairs Medical Center

People needed

110

Starts

2016-08-01

Last updated by the study team

2016-11-15

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• James J. Peters VA Medical Center — The Bronx, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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