Status:

COMPLETED

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

Lead Sponsor:

National Heart, Lung, and Blood Institute (NHLBI)

Conditions:

Pulmonary Disease

Oropharyngeal Disease

Eligibility:

All Genders

18-99 years

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 ma...

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 ga...

Eligibility Criteria

Inclusion

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

Exclusion

    Key Trial Info

    Start Date :

    September 18 2006

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    October 27 2016

    Estimated Enrollment :

    157 Patients enrolled

    Trial Details

    Trial ID

    NCT00366509

    Start Date

    September 18 2006

    End Date

    October 27 2016

    Last Update

    August 2 2021

    Active Locations (1)

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    1

    National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, United States, 20892