GERD and Anti-Reflux Therapy Between Able-bodied and SCI Individuals
- Conditions
- Gastro Esophageal Reflux Disorder
- Interventions
- Device: 24 Hour pH MonitorProcedure: Pulmonary Function ExaminationProcedure: Exhaled Nitric OxideProcedure: Exhaled Breath Concentrate (EBC)Procedure: Bernstein's Acid Clearance TestProcedure: Esophageal Motility
- Registration Number
- NCT02584751
- Lead Sponsor
- James J. Peters Veterans Affairs Medical Center
- Brief 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.
- Detailed Description
Complete or partial loss of respiratory muscle innervation in individuals with cervical (C1-8) and high thoracic (T1-6) injuries leads to inadequate ventilation and inability to effectively clear secretions, often prompting supportive ventilation following initial injury. Development of atelectasis, pneumonias and respiratory failure are the most common respiratory complications observed during the acute phase of injury. The role of chronic airway inflammation on pulmonary function in persons with SCI is unknown, although the investigators' recent work has shown that individuals with cervical SCI have elevated levels of exhaled nitric oxide (NO), comparable to those seen in mild asthma. It is now widely believed that in the airways of asthmatic patients, the release of NO represents a physiological mechanism to counteract the bronchoconstriction caused by various stimuli. In persons with cervical SCI, bronchoconstriction may represent a consequence of unopposed parasympathetic influence, but alternative mechanisms, such as recurrent infections secondary to impaired cough effectiveness, systemic inflammatory response following SCI, or extra-esophageal manifestations of underlying esophageal dysmotility and/or GERD need to be evaluated. In general population, it has been long recognized that esophageal dysmotility and/or GERD may lead to extra-esophageal manifestations. Reflux can affect both upper and lower respiratory systems leading to the variety of extra-esophageal manifestations, such as reflux asthma, chronic cough, hoarseness, chronic sinusitis, laryngitis, loss of dental enamel, idiopathic pulmonary fibrosis, recurrent pneumonia, chronic bronchitis, etc. 2 possible mechanisms of these complications have been identified: the direct aspiration of reflux content and indirectly, stimulation of vagally-mediated reflexes. Regardless of the underlying mechanisms, treatments with acid-reducing therapies have shown improvement in GERD and extra-esophageal manifestations of the disease the general population. 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 110
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Able-Bodied non-GERD 24 Hour pH Monitor Able-bodied patients who are not diagnosed with GERD during screening will act as controls. SCI non-GERD 24 Hour pH Monitor SCI patients who are not diagnosed with GERD during screening will act as controls SCI non-GERD Esophageal Motility SCI patients who are not diagnosed with GERD during screening will act as controls Able-bodied GERD 24 Hour pH Monitor For those AB subjects who are identified with GERD will act as controls. Note they will not receive treatment for GERD in this study. We will notify their primary care physician during the study so that they may receive treatment. Able-Bodied non-GERD Pulmonary Function Examination Able-bodied patients who are not diagnosed with GERD during screening will act as controls. Able-Bodied non-GERD Bernstein's Acid Clearance Test Able-bodied patients who are not diagnosed with GERD during screening will act as controls. SCI non-GERD Pulmonary Function Examination SCI patients who are not diagnosed with GERD during screening will act as controls Able-Bodied non-GERD Exhaled Nitric Oxide Able-bodied patients who are not diagnosed with GERD during screening will act as controls. Able-Bodied non-GERD Exhaled Breath Concentrate (EBC) Able-bodied patients who are not diagnosed with GERD during screening will act as controls. SCI GERD 24 Hour pH Monitor For those SCI subjects who are identified with GERD, they will undergo a 8week treatment of Omeprazole to reduce GERD SCI GERD Esophageal Motility For those SCI subjects who are identified with GERD, they will undergo a 8week treatment of Omeprazole to reduce GERD Able-Bodied non-GERD Esophageal Motility Able-bodied patients who are not diagnosed with GERD during screening will act as controls. SCI non-GERD Bernstein's Acid Clearance Test SCI patients who are not diagnosed with GERD during screening will act as controls SCI GERD Exhaled Nitric Oxide For those SCI subjects who are identified with GERD, they will undergo a 8week treatment of Omeprazole to reduce GERD SCI GERD Exhaled Breath Concentrate (EBC) For those SCI subjects who are identified with GERD, they will undergo a 8week treatment of Omeprazole to reduce GERD Able-bodied GERD Exhaled Nitric Oxide For those AB subjects who are identified with GERD will act as controls. Note they will not receive treatment for GERD in this study. We will notify their primary care physician during the study so that they may receive treatment. SCI non-GERD Exhaled Nitric Oxide SCI patients who are not diagnosed with GERD during screening will act as controls SCI non-GERD Exhaled Breath Concentrate (EBC) SCI patients who are not diagnosed with GERD during screening will act as controls SCI GERD Bernstein's Acid Clearance Test For those SCI subjects who are identified with GERD, they will undergo a 8week treatment of Omeprazole to reduce GERD Able-bodied GERD Pulmonary Function Examination For those AB subjects who are identified with GERD will act as controls. Note they will not receive treatment for GERD in this study. We will notify their primary care physician during the study so that they may receive treatment. Able-bodied GERD Esophageal Motility For those AB subjects who are identified with GERD will act as controls. Note they will not receive treatment for GERD in this study. We will notify their primary care physician during the study so that they may receive treatment. SCI GERD Pulmonary Function Examination For those SCI subjects who are identified with GERD, they will undergo a 8week treatment of Omeprazole to reduce GERD Able-bodied GERD Exhaled Breath Concentrate (EBC) For those AB subjects who are identified with GERD will act as controls. Note they will not receive treatment for GERD in this study. We will notify their primary care physician during the study so that they may receive treatment. Able-bodied GERD Bernstein's Acid Clearance Test For those AB subjects who are identified with GERD will act as controls. Note they will not receive treatment for GERD in this study. We will notify their primary care physician during the study so that they may receive treatment. SCI GERD Omeprazole For those SCI subjects who are identified with GERD, they will undergo a 8week treatment of Omeprazole to reduce GERD
- Primary Outcome Measures
Name Time Method DeMeester Score 24hours A DeMeester score will be calculated from the 24hour pH monitoring to determine if an individual has GERD.
- Secondary Outcome Measures
Name Time Method Pulmonary Function Tests 2days Pulmonary Function values and results will be compared to one another to determine if a protein pump inhibitor treatment decreases GERD and improves pulmonary function
Symptom Surveys and Questionnaires 2days An 11 question survey assessing GERD and a 15 question survey assessing dysphagia or difficulty swallowing will be used to confirm diagnosis of GERD and compared across the various groups.
Trial Locations
- Locations (1)
James J. Peters VA Medical Center
🇺🇸Bronx, New York, United States