- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00366509
Role of Helicobacter Pylori and Its Toxins in Lung and Digestive System Diseases
Role of Helicobacter Pylori and Its Toxins in Pulmonary and Oropharyngeal Disease
This study will examine bacteria and toxins in the mouth, lung and digestive system that may be the cause of various diseases or symptoms. H. pylori is a bacterium that produces various toxins that may contribute to lung problems. This study will examine specimens collected from the mouth, teeth, lung, digestive tract and blood to measure H. pylori and its toxins and their effects on cells.
People 18 years of age and older with or without gastrointestinal disease may be eligible for this study. These include people without a history of lung disease as well as patients with any of the following: lymphangioleiomyomatosis, asthma, sarcoidosis, other chronic or genetic lung disease (e.g., chronic obstructive pulmonary disease, cystic fibrosis or eosinophilic granuloma).
Participants may undergo the following tests:
- Blood and urine tests, chest x-ray.
- Measurement of arterial blood gases: A small needle is placed in an artery in the forearm to collect arterial blood.
- Lung function tests: Subjects breathe deeply and occasionally hold their breath. They may also receive a medication that expands the airways.
- Fiberoptic bronchoscopy with lavage and bronchial brushing: The subject's mouth and throat are numbed with lidocaine; a sedative may be given for comfort. A thin flexible tube called a bronchoscope is advanced through the nose or mouth into the lung airways to examine the airways. Saline (salt water) is then injected through the bronchoscope into the air passage and then removed by gentle suction. Next, a small brush is passed through the bronchoscope and an area of the airway is brushed to collect some cells for examination.
- Mouth rinsing or teeth brushing to collect cells.
- Endoscopy: A small needle and catheter (thin plastic tube) are placed into an arm vein to administer fluids and medications through the vein. A sedative may be given. The throat is numbed with lidocaine and a thin flexible tube called an endoscope is inserted through the mouth and down the esophagus into the stomach and upper part of the small intestine to examine those areas.
Study Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
- INCLUSION CRITERIA:
Individuals who are 18 years of age or older with or without a history of gastrointestinal disease and with any of the following:
- lymphangioleiomyomatosis, or
- asthma, or
- sarcoidosis, or
- pulmonary fibrosis, or
- other chronic or genetic lung diseases (e.g., chronic obstructive pulmonary disease, eosinophilic granuloma, cystic fibrosis, Wegener's granulomatosis, chronic bronchitis), or
- research volunteers without a history of lung disease.
EXCLUSION CRITERIA:
Individuals with any of the following:
- uncontrolled ischemic heart disease, or
- uncorrectable bleeding diathesis, or
- pregnancy or lactation, or
- inability to give informed consent, or
- risk factors for endocarditis (e.g., prosthetic cardiac valve, previous bacterial endocarditis, surgically constructed systemic pulmonary shunts or conduits, complex cyanotic congenital heart disease [e.g., single ventricle, transposition of great arteries, tetralogy of Fallot])
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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2
Healthy volunteer
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1
Lung Disease
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
procure and analyze gastrointestinal, oropharyngeal, lung and/or blood specimens from healthy research volunteers and subjects with lung disease
Time Frame: ongoing
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Procure and analyze gastrointestinal, oropharyngeal, lung and/or blood specimens from healthy research volunteers and subjects with lung disease (e. g., lymphangioleiomyomatosis, asthma, sarcoidosis, pulmonary fibrosis).
Comparison of specimens from subjects may further the understanding of H. pylori, VacA cytotoxin, and/or other toxins in oropharyngeal, pulmonary, and gastrointestinal conditions.
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ongoing
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Collaborators and Investigators
Publications and helpful links
General Publications
- Cover TL, Blanke SR. Helicobacter pylori VacA, a paradigm for toxin multifunctionality. Nat Rev Microbiol. 2005 Apr;3(4):320-32. doi: 10.1038/nrmicro1095.
- Hocker M, Hohenberger P. Helicobacter pylori virulence factors--one part of a big picture. Lancet. 2003 Oct 11;362(9391):1231-3. doi: 10.1016/S0140-6736(03)14547-3.
- Israel DA, Peek RM. pathogenesis of Helicobacter pylori-induced gastric inflammation. Aliment Pharmacol Ther. 2001 Sep;15(9):1271-90. doi: 10.1046/j.1365-2036.2001.01052.x.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Respiratory Tract Diseases
- Immune System Diseases
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphangiomyoma
- Lymphatic Vessel Tumors
- Perivascular Epithelioid Cell Neoplasms
- Fibrosis
- Lung Diseases
- Pulmonary Fibrosis
- Lymphangioleiomyomatosis
- Sarcoidosis
Other Study ID Numbers
- 060222
- 06-H-0222
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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