CompletedNot applicableNCT00366509

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

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.

Checked against the public recordLast updated Aug 2, 2021 · Source: ClinicalTrials.gov

StatusCompleted
PhaseNot applicable
U.S. locations1
SponsorNational Heart, Lung, and Blood Institute (NHLBI)
01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Interventions being studied
Not specified
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

* 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 \[e.g., single ventricle, transposition of great arteries, tetralogy of Fallot\])

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 2, 2021. Always confirm current availability with the study team.

View original record ↗