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Sponsor study identifier
Secondary identifiers
observational
157
1 country
1
Study Start
September 18, 2006
Actual (reported)Primary Completion
January 1, 2016
Actual (reported)Study Completion
October 27, 2016
Actual (reported)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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 27, 2016
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 17, 2006
Actual (reported)August 21, 2006
Actual (reported)September 18, 2006
Actual (reported)January 1, 2016
Actual (reported)October 27, 2016
Actual (reported)procure and analyze gastrointestinal, oropharyngeal, lung and/or blood specimens from healthy research volunteers and subjects with lung disease
Procure and analyze gastrointestinal, oropharyngeal, lung and/or blood specimens from healthy research volunteers and subjects with lung disease (e. g., lymphangioleiomyomatosis, asthma, sarcoidosis, pulmonary fibrosis). Comparison of specimens from subjects may further the understanding of H. pylori, VacA cytotoxin, and/or other toxins in oropharyngeal, pulmonary, and gastrointestinal conditions.
ongoing
Lung Disease
Healthy volunteer
139 patient volunteers and 18 healthy research volunteers have participated in this protocol at the NIH. 133 female patients with lymphangioleiomyomatosis (age range at accrual from 22 to 72 years old: 121 white, 7 black, 4 asian, and 1 unknown). 2 female patients with other chronic/genetic lung diseases (age range at accrual from 47 to 71: 2 white). 4 male patients with pulmonary fibrosis (age range at accrual from 67 to 74: 4 white). 18 research volunteers without lung disease (age range at accrual from 19 to 67: 6 white males, 5 white females, 5 black females, 1 hispanic multi-race male, and 1 hispanic unknown male.
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
Cover TL, Blanke SR. Helicobacter pylori VacA, a paradigm for toxin multifunctionality. Nat Rev Microbiol. 2005 Apr;3(4):320-32. doi: 10.1038/nrmicro1095.
Hocker M, Hohenberger P. Helicobacter pylori virulence factors--one part of a big picture. Lancet. 2003 Oct 11;362(9391):1231-3. doi: 10.1016/S0140-6736(03)14547-3.
Israel DA, Peek RM. pathogenesis of Helicobacter pylori-induced gastric inflammation. Aliment Pharmacol Ther. 2001 Sep;15(9):1271-90. doi: 10.1046/j.1365-2036.2001.01052.x.
Joel Moss, M.D.
National Heart, Lung, and Blood Institute (NHLBI)
157 participants (actual enrollment reported by the registry).
First Submitted
August 17, 2006
First Posted
August 21, 2006
Study Start
September 18, 2006
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
January 1, 2016
Actual (reported)Study Completion
October 27, 2016
Actual (reported)Last Updated
August 2, 2021
Record last verified: 2021-07
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Source: ClinicalTrials.gov.
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