GERD and Anti-Reflux Therapy Between Able-bodied and SCI Individuals
Comparison of GERD and the Effects of Anti-Reflux Therapy on Pulmonary Function Between Able-Bodied and SCI Individuals
1 other identifier
interventional
110
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 9, 2015
CompletedFirst Posted
Study publicly available on registry
October 23, 2015
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedNovember 15, 2016
November 1, 2016
2 years
October 9, 2015
November 14, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
DeMeester Score
A DeMeester score will be calculated from the 24hour pH monitoring to determine if an individual has GERD.
24hours
Secondary Outcomes (2)
Pulmonary Function Tests
2days
Symptom Surveys and Questionnaires
2days
Study Arms (4)
Able-Bodied non-GERD
ACTIVE COMPARATORAble-bodied patients who are not diagnosed with GERD during screening will act as controls.
SCI non-GERD
ACTIVE COMPARATORSCI patients who are not diagnosed with GERD during screening will act as controls
SCI GERD
EXPERIMENTALFor those SCI subjects who are identified with GERD, they will undergo a 8week treatment of Omeprazole to reduce GERD
Able-bodied GERD
ACTIVE COMPARATORFor 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.
Interventions
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
Monitors the acidity and levels of pH in the esophagus for 24hours and helps diagnose people with GERD
Assess pulmonary function such as lung volumes, spirometry, and max inspiration/expiration pressures.
Used to measure inflammation markers for airway resistance.
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.
Bernstein test is a clinical test for the diagnosis of chest pain in association with gastric acid exposure
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.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
James J. Peters VA Medical Center
The Bronx, New York, 10468, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Researcher
Study Record Dates
First Submitted
October 9, 2015
First Posted
October 23, 2015
Study Start
August 1, 2016
Primary Completion
August 1, 2018
Last Updated
November 15, 2016
Record last verified: 2016-11