Protocol Number: 06-H-0222

Title:

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

Number:

06-H-0222

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 down the esophagus into the stomach and upper part of the small intestine to examine those areas.

Sponsoring Institute:

National Heart, Lung and Blood Institute (NHLBI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility 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])

Special Instructions:

Currently Not Provided

Keywords:

Vac A Toxin

Lung

Bronchoscopy

Endoscopy

Cytotoxin

Recruitment Keyword(s):

Pulmonary Disease

Lung Disease

Genetic Disease

Oropharyngeal Disease

Pulmonary Fibrosis

Asthma

Condition(s):

Pulmonary Disease

Oropharyngeal Disease

Lymphangioleiomyomatosis

Pulmonary Fibrosis

Asthma

Sarcoidosis

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Heart, Lung and Blood Institute

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Cover TL, Blanke SR. Helicobacter pylori VacA, a paradigm for toxin multifunctionality. Nat Rev Microbiol. 2005 Apr;3(4):320-32. Review.

Hocker M, Hohenberger P. Helicobacter pylori virulence factors--one part of a big picture. Lancet. 2003 Oct 11;362(9391):1231-3.

Israel DA, Peek RM. pathogenesis of Helicobacter pylori-induced gastric inflammation. Aliment Pharmacol Ther. 2001 Sep;15(9):1271-90. Review.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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