Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00366509
Status:
COMPLETED
Last Update Posted:
2021-08-02
First Post:
2006-08-17
Brief Title:
Role of Helicobacter Pylori and Its Toxins in Lung and Digestive System Diseases
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Role of Helicobacter Pylori and Its Toxins in Pulmonary and Oropharyngeal Disease
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 eg 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 subjects 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
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 eg 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 subjects 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
Detailed Description:
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 andor 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 andor blood specimens from healthy research volunteers and subjects with lung disease eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-H-0222 | None | None | None |