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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00366509
First received: August 17, 2006
Last updated: March 14, 2014
Last verified: February 2014
  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.

Condition
Pulmonary Disease
Oropharyngeal Disease
Lymphangioleiomyomatosis
Pulmonary Fibrosis
Asthma
Sarcoidosis

Study Type: Observational
Official Title: Role of Helicobacter Pylori and Its Toxins in Pulmonary and Oropharyngeal Disease

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 400
Study Start Date: August 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

  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])
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00366509

Contacts
Contact: Mary Haughey, R.N. (301) 496-3632 mhaughey@nhlbi.nih.gov
Contact: Joel Moss, M.D. (301) 496-1597 mossj@nhlbi.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Japan
Kobe Medical Center Recruiting
Kobe, Japan
Sponsors and Collaborators
Investigators
Principal Investigator: Joel Moss, M.D. National Heart, Lung, and Blood Institute (NHLBI)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00366509     History of Changes
Other Study ID Numbers: 060222, 06-H-0222
Study First Received: August 17, 2006
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Vac A Toxin
Lung
Bronchoscopy
Endoscopy
Cytotoxin
Pulmonary Disease
Lung Disease
Genetic Disease
Oropharyngeal Disease
Pulmonary Fibrosis
Asthma

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Lung Diseases
Sarcoidosis
Digestive System Diseases
Lymphangioleiomyomatosis
Pathologic Processes
Respiratory Tract Diseases
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

ClinicalTrials.gov processed this record on September 16, 2014