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Role of Helicobacter Pylori and Its Toxins in Pulmonary and Oropharyngeal Disease

18 Years
Open (Enrolling)
Pulmonary Disease, Oropharyngeal Disease, Lymphangioleiomyomatosis, Pulmonary Fibrosis, Asthma, Sarcoidosis

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Trial Information

Role of Helicobacter Pylori and Its Toxins in Pulmonary and Oropharyngeal Disease

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.

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.


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])

Type of Study:


Study Design:


Principal Investigator

Joel Moss, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Heart, Lung, and Blood Institute (NHLBI)


United States: Federal Government

Study ID:




Start Date:

August 2006

Completion Date:

Related Keywords:

  • Pulmonary Disease
  • Oropharyngeal Disease
  • Lymphangioleiomyomatosis
  • Pulmonary Fibrosis
  • Asthma
  • Sarcoidosis
  • Vac A Toxin
  • Lung
  • Bronchoscopy
  • Endoscopy
  • Cytotoxin
  • Pulmonary Disease
  • Lung Disease
  • Genetic Disease
  • Oropharyngeal Disease
  • Pulmonary Fibrosis
  • Asthma
  • Asthma
  • Digestive System Diseases
  • Gastrointestinal Diseases
  • Fibrosis
  • Lung Diseases
  • Respiration Disorders
  • Pulmonary Fibrosis
  • Sarcoidosis
  • Lymphangioleiomyomatosis



National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda, Maryland  20892