Role of Helicobacter Pylori and Its Toxins in Lung and Digestive System Diseases
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|ClinicalTrials.gov Identifier: NCT00366509|
Recruitment Status : Completed
First Posted : August 21, 2006
Last Update Posted : April 1, 2021
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.
|Condition or disease|
|Pulmonary Disease Oropharyngeal Disease Lymphangioleiomyomatosis Pulmonary Fibrosis Asthma Sarcoidosis|
|Study Type :||Observational|
|Actual Enrollment :||157 participants|
|Official Title:||Role of Helicobacter Pylori and Its Toxins in Pulmonary and Oropharyngeal Disease|
|Actual Study Start Date :||September 18, 2006|
- procure and analyze gastrointestinal, oropharyngeal, lung and/or blood specimens from healthy research volunteers and subjects with lung disease [ Time Frame: ongoing ]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.
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): NCT00366509
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Joel Moss, M.D.||National Heart, Lung, and Blood Institute (NHLBI)|