ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    GERD | Veterans Affairs Medical Center [Lead]
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02584751
Recruitment Status : Unknown
Verified November 2016 by Miroslav Radulovic, M.D., James J. Peters Veterans Affairs Medical Center.
Recruitment status was:  Recruiting
First Posted : October 23, 2015
Last Update Posted : November 15, 2016
Sponsor:
Information provided by (Responsible Party):
Miroslav Radulovic, M.D., 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.

Condition or disease Intervention/treatment Phase
Gastro Esophageal Reflux Disorder Drug: Omeprazole Device: 24 Hour pH Monitor Procedure: Pulmonary Function Examination Procedure: Exhaled Nitric Oxide Procedure: Exhaled Breath Concentrate (EBC) Procedure: Bernstein's Acid Clearance Test Procedure: Esophageal Motility Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of GERD and the Effects of Anti-Reflux Therapy on Pulmonary Function Between Able-Bodied and SCI Individuals
Study Start Date : August 2016
Estimated Primary Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
Active Comparator: Able-Bodied non-GERD
Able-bodied patients who are not diagnosed with GERD during screening will act as controls.
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.

Active Comparator: SCI non-GERD
SCI patients who are not diagnosed with GERD during screening will act as controls
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.

Experimental: SCI GERD
For those SCI subjects who are identified with GERD, they will undergo a 8week treatment of Omeprazole to reduce GERD
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.

Active Comparator: Able-bodied GERD
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.
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.




Primary Outcome Measures :
  1. DeMeester Score [ Time Frame: 24hours ]
    A DeMeester score will be calculated from the 24hour pH monitoring to determine if an individual has GERD.


Secondary Outcome Measures :
  1. Pulmonary Function Tests [ Time Frame: 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

  2. Symptom Surveys and Questionnaires [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02584751


Contacts
Contact: Miroslav Radulovic, MD 718-584-9000 ext 5472 miroslav.radulovic@va.gov
Contact: Tradd Cummings, MS 718-584-9000 ext 3107 tradd.cummings@va.gov

Locations
United States, New York
James J. Peters VA Medical Center Recruiting
Bronx, New York, United States, 10468
Contact: Tradd Cummings, MS    718-584-9000 ext 3107    tradd.cummings@va.gov   
Contact: Josh Hobson, MS    (718) 584-9000 ext 3129    joshua.hobson@va.gov   
Sub-Investigator: Mark A Korsten, MD         
Principal Investigator: Miroslav Radulovic, MD         
Sub-Investigator: Marinella D. Galea, MD         
Sub-Investigator: Gregory Schilero, MD         
Sponsors and Collaborators
James J. Peters Veterans Affairs Medical Center

Responsible Party: Miroslav Radulovic, M.D., Associate Researcher, James J. Peters Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT02584751     History of Changes
Other Study ID Numbers: RAD-16-02
First Posted: October 23, 2015    Key Record Dates
Last Update Posted: November 15, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Omeprazole
Nitric Oxide
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents