Role of Helicobacter Pylori and Its Toxins in Lung and Digestive System Diseases

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ClinicalTrials.gov Identifier: NCT00366509

Recruitment Status : Completed

First Posted : August 21, 2006

Last Update Posted : March 29, 2018

Sponsor:

Information provided by (Responsible Party):

National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Study Description

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 (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.

Condition or disease
Pulmonary Disease Oropharyngeal Disease Lymphangioleiomyomatosis Pulmonary Fibrosis Asthma Sarcoidosis

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 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.

Study Design


Study Type :	Observational
Actual Enrollment :	157 participants
Official Title:	Role of Helicobacter Pylori and Its Toxins in Pulmonary and Oropharyngeal Disease
Study Start Date :	August 8, 2006

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Lymphangioleiomyomatosis

MedlinePlus related topics: Digestive Diseases

Genetic and Rare Diseases Information Center resources: Lymphangioleiomyomatosis

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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:

lymphangioleiomyomatosis, or
asthma, or
sarcoidosis, or
pulmonary fibrosis, or
other chronic or genetic lung diseases (e.g., chronic obstructive pulmonary disease, eosinophilic granuloma, cystic fibrosis, Wegener's granulomatosis, chronic bronchitis), or
research volunteers without a history of lung disease.

EXCLUSION CRITERIA:

Individuals with any of the following:

uncontrolled ischemic heart disease, or
uncorrectable bleeding diathesis, or
pregnancy or lactation, or
inability to give informed consent, or
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])

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00366509

Locations


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

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators


Principal Investigator:	Joel Moss, M.D.	National Heart, Lung, and Blood Institute (NHLBI)

More Information

Additional Information:

NIH Clinical Center Detailed Web Page This link exits the ClinicalTrials.gov site

Publications:

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

Höcker 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.


Responsible Party:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00366509 History of Changes
Other Study ID Numbers:	060222 06-H-0222
First Posted:	August 21, 2006 Key Record Dates
Last Update Posted:	March 29, 2018
Last Verified:	October 16, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):


Vac A Toxin Lung Bronchoscopy Endoscopy Cytotoxin Pulmonary Disease	Lung Disease Genetic Disease Oropharyngeal Disease Pulmonary Fibrosis Asthma

Additional relevant MeSH terms:


Lung Diseases Fibrosis Pulmonary Fibrosis Sarcoidosis Digestive System Diseases Lymphangioleiomyomatosis Respiratory Tract Diseases Pathologic Processes Lymphoproliferative Disorders	Lymphatic Diseases Lymphangiomyoma Lymphatic Vessel Tumors Neoplasms by Histologic Type Neoplasms Perivascular Epithelioid Cell Neoplasms Neoplasms, Connective and Soft Tissue Immunoproliferative Disorders Immune System Diseases

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