| Conditions: |
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Pulmonary Disease - Oropharyngeal Disease - Lymphangioleiomyomatosis - Pulmonary Fibrosis - Asthma - Sarcoidosis |
| Purpose: |
|
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 Summary: |
|
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.
|
| Criteria: |
|
- 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:
1. lymphangioleiomyomatosis, or
2. asthma, or
3. sarcoidosis, or
4. pulmonary fibrosis, or
5. other chronic or genetic lung diseases (e.g., chronic obstructive pulmonary disease,
eosinophilic granuloma, cystic fibrosis, Wegener's granulomatosis, chronic
bronchitis), or
6. research volunteers without a history of lung disease.
EXCLUSION CRITERIA:
Individuals with any of the following:
1. uncontrolled ischemic heart disease, or
2. uncorrectable bleeding diathesis, or
3. pregnancy or lactation, or
4. inability to give informed consent, or
5. 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])
|
| NCT ID: |
|
NCT00366509 |
| Primary Contact: |
|
Principal Investigator
Joel Moss, M.D.
National Heart, Lung, and Blood Institute (NHLBI)
Mary Haughey, R.N.
Phone: (301) 496-3632
Email: mhaughey@nhlbi.nih.gov
|
| Backup Contact: |
|
Email: mossj@nhlbi.nih.gov
Joel Moss, M.D.
Phone: (301) 496-3632
|
| Location Contact: |
|
Bethesda, Maryland 20892
United States
For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)
Phone: 800-411-1222
Email: prpl@mail.cc.nih.gov
Site Status: Recruiting |