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NCT00366509 · ClinicalTrials.gov registry record
Role of Helicobacter Pylori and Its Toxins in Lung and Digestive System Diseases
A clinical trial, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- 157
- Enrollment target
NCT00366509: Completed study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT00366509 is a clinical trial that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 157 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00366509 has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- 157 participants
- Enrollment target
Study Summary
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 dow
Primary Outcome
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 157 participants |
| Start Date | 2006-09-18 |
| Est. Completion | 2016-10-27 |
What the finished NCT00366509 record still lists
NCT00366509 is an observational study that tracks outcomes without assigning an intervention. The registered 157 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT00366509 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00366509 about?
NCT00366509 is a clinical study titled "Role of Helicobacter Pylori and Its Toxins in Lung and Digestive System Diseases". 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, lu...
What is the current status of trial NCT00366509?
This trial is currently completed. The enrollment target is 157 participants. The study started on 2006-09-18. Estimated completion is 2016-10-27.
Who is sponsoring clinical trial NCT00366509?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
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