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

NCT ID: NCT02584751

Last Updated: 2016-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Brief Summary

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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

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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.

Conditions

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Gastro Esophageal Reflux Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Able-Bodied non-GERD

Able-bodied patients who are not diagnosed with GERD during screening will act as controls.

Group Type ACTIVE_COMPARATOR

24 Hour pH Monitor

Intervention Type DEVICE

Monitors the acidity and levels of pH in the esophagus for 24hours and helps diagnose people with GERD

Pulmonary Function Examination

Intervention Type PROCEDURE

Assess pulmonary function such as lung volumes, spirometry, and max inspiration/expiration pressures.

Exhaled Nitric Oxide

Intervention Type PROCEDURE

Used to measure inflammation markers for airway resistance.

Exhaled Breath Concentrate (EBC)

Intervention Type PROCEDURE

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's Acid Clearance Test

Intervention Type PROCEDURE

Bernstein test is a clinical test for the diagnosis of chest pain in association with gastric acid exposure

Esophageal Motility

Intervention Type PROCEDURE

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.

SCI non-GERD

SCI patients who are not diagnosed with GERD during screening will act as controls

Group Type ACTIVE_COMPARATOR

24 Hour pH Monitor

Intervention Type DEVICE

Monitors the acidity and levels of pH in the esophagus for 24hours and helps diagnose people with GERD

Pulmonary Function Examination

Intervention Type PROCEDURE

Assess pulmonary function such as lung volumes, spirometry, and max inspiration/expiration pressures.

Exhaled Nitric Oxide

Intervention Type PROCEDURE

Used to measure inflammation markers for airway resistance.

Exhaled Breath Concentrate (EBC)

Intervention Type PROCEDURE

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's Acid Clearance Test

Intervention Type PROCEDURE

Bernstein test is a clinical test for the diagnosis of chest pain in association with gastric acid exposure

Esophageal Motility

Intervention Type PROCEDURE

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.

SCI GERD

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

Group Type EXPERIMENTAL

Omeprazole

Intervention Type DRUG

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

24 Hour pH Monitor

Intervention Type DEVICE

Monitors the acidity and levels of pH in the esophagus for 24hours and helps diagnose people with GERD

Pulmonary Function Examination

Intervention Type PROCEDURE

Assess pulmonary function such as lung volumes, spirometry, and max inspiration/expiration pressures.

Exhaled Nitric Oxide

Intervention Type PROCEDURE

Used to measure inflammation markers for airway resistance.

Exhaled Breath Concentrate (EBC)

Intervention Type PROCEDURE

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's Acid Clearance Test

Intervention Type PROCEDURE

Bernstein test is a clinical test for the diagnosis of chest pain in association with gastric acid exposure

Esophageal Motility

Intervention Type PROCEDURE

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.

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.

Group Type ACTIVE_COMPARATOR

24 Hour pH Monitor

Intervention Type DEVICE

Monitors the acidity and levels of pH in the esophagus for 24hours and helps diagnose people with GERD

Pulmonary Function Examination

Intervention Type PROCEDURE

Assess pulmonary function such as lung volumes, spirometry, and max inspiration/expiration pressures.

Exhaled Nitric Oxide

Intervention Type PROCEDURE

Used to measure inflammation markers for airway resistance.

Exhaled Breath Concentrate (EBC)

Intervention Type PROCEDURE

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's Acid Clearance Test

Intervention Type PROCEDURE

Bernstein test is a clinical test for the diagnosis of chest pain in association with gastric acid exposure

Esophageal Motility

Intervention Type PROCEDURE

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.

Interventions

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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

Intervention Type DRUG

24 Hour pH Monitor

Monitors the acidity and levels of pH in the esophagus for 24hours and helps diagnose people with GERD

Intervention Type DEVICE

Pulmonary Function Examination

Assess pulmonary function such as lung volumes, spirometry, and max inspiration/expiration pressures.

Intervention Type PROCEDURE

Exhaled Nitric Oxide

Used to measure inflammation markers for airway resistance.

Intervention Type 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.

Intervention Type PROCEDURE

Bernstein's Acid Clearance Test

Bernstein test is a clinical test for the diagnosis of chest pain in association with gastric acid exposure

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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James J. Peters Veterans Affairs Medical Center

FED

Sponsor Role lead

Responsible Party

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Miroslav Radulovic, M.D.

Associate Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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James J. Peters VA Medical Center

The Bronx, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Miroslav Radulovic, MD

Role: CONTACT

Phone: 718-584-9000

Email: [email protected]

Tradd Cummings, MS

Role: CONTACT

Phone: 718-584-9000

Email: [email protected]

Facility Contacts

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Tradd Cummings, MS

Role: primary

Josh Hobson, MS

Role: backup

Other Identifiers

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RAD-16-02

Identifier Type: -

Identifier Source: org_study_id