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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00366509 |
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:
Condition |
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Pulmonary Disease Oropharyngeal Disease Lymphangioleiomyomatosis Pulmonary Fibrosis Asthma Sarcoidosis |
Study Type: | Observational |
Official Title: | Role of Helicobacter Pylori and Its Toxins in Pulmonary and Oropharyngeal Disease |
Estimated Enrollment: | 200 |
Study Start Date: | August 2006 |
Vacuolating cytotoxin A (VacA toxin), an 88-kDa multifunctional protein, and other toxins are produced by Helicobacter pylori. We hypothesize that H. pylori, VacA toxin, and other toxins within the gastrointestinal tract and/or oropharynx are also found in the lung and may contribute to decline in lung function. Analyses of gastrointestinal, oropharyngeal, lung and blood specimens will improve the understanding of H. pylori, VacA toxin, and other toxins as well as their potential role in pathophysiology of disease. The objectives of this exploratory protocol are to procure gastrointestinal, oropharyngeal, lung and/or blood specimens from healthy research volunteers and subjects with lung disease (e.g., lymphangioleiomyomatosis, asthma, sarcoidosis, pulmonary fibrosis) and to analyze these specimens for H. pylori, VacA toxin, and other toxins. We hypothesize that the toxins may have a role in the pathogenesis of lung disease and in the subclinical decline in lung function seen with aging.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Individuals who are 18 years of age or older with or without a history of gastrointestinal disease and with any of the following:
EXCLUSION CRITERIA:
Individuals with any of the following:
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 | |
Japan | |
Kobe Medical Center | Recruiting |
Kobe, Japan |
Study ID Numbers: | 060222, 06-H-0222 |
Study First Received: | August 17, 2006 |
Last Updated: | July 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00366509 |
Health Authority: | United States: Federal Government |
Vac A Toxin Lung Bronchoscopy Endoscopy Cytotoxin Pulmonary Disease |
Lung Disease Genetic Disease Oropharyngeal Disease Pulmonary Fibrosis Asthma |
Lung Diseases, Interstitial Immunoproliferative Disorders Fibrosis Respiration Disorders Lymphangiomyoma Asthma Sarcoidosis Pulmonary Fibrosis Lymphatic Diseases |
Lymphangioleiomyomatosis Lung Diseases, Obstructive Hypersensitivity Digestive System Diseases Respiratory Tract Diseases Lung Diseases Hypersensitivity, Immediate Lymphoproliferative Disorders Respiratory Hypersensitivity |
Lymphatic Vessel Tumors Neoplasms Neoplasms by Histologic Type |
Pathologic Processes Immune System Diseases Bronchial Diseases |