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Lymphocytic Subsets and Cytokine Production With H. Pylori Infection

This study has been completed.
Study NCT00173953.   Last updated on September 13, 2005.   Information provided by National Taiwan University Hospital

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Descriptive Information Fields
Brief Title  Lymphocytic Subsets and Cytokine Production With H. Pylori Infection
Official Title  Lymphocytic Subsets and Cytokine Production in the Gastric Samples of Patients With Helicobacter Pylori Infection
Brief Summary

The aims of this study are 1) to determine the cytokines produced by both Th1 and Th2 subsets in gastric antral biopsy specimens from Taiwanese patients before and after anti H. pylori therapy; 2) to obtain a detailed phenotypic characterization and distribution pattern of mucosal lymphocytes in H. pylori-associated gastritis and to define possible contributing immune mechanisms responsible for the chronicity of the disease and its associated lesions.

Detailed Description

Helicobacter pylori, a Gram-negative spiral bacterium, has been first isolated from a patient with chronic active gastritis since 1982. Recent studies strongly suggest that chronic infection with H. pylori is tightly associated with chronic gastritis, peptic ulcer, and gastric carcinoma. However, only a minority of infected people develop signs and symptoms of gastric pathology. Thus, both host and microbial factors may lead to different outcomes of infection. In spite of high prevalence in general population and increasing clinical attention has been paid on this infection, the knowledge of pathogenic mechanism of H. pylori infection is still limited and little is known about the role of host immune response in the pathogenesis of disease.The aims of this study are 1) to determine the cytokines produced by both Th1 and Th2 subsets in gastric antral biopsy specimens from Taiwanese patients before and after anti H. pylori therapy; 2) to obtain a detailed phenotypic characterization and distribution pattern of mucosal lymphocytes in H. pylori-associated gastritis and to define possible contributing immune mechanisms responsible for the chronicity of the disease and its associated lesions.

Study Phase
Study Type  Interventional
Study Design  Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Primary Outcome Measure  Cytokines produced by both Th1 / Th2 subsets in gastric antral biopsy specimens from Taiwanese patients before and after anti H. pylori therapy.
Secondary Outcome Measure  Obtain a detailed phenotypic characterization and distribution pattern of mucosal lymphocytes in H. pylori-associated gastritis and to define immune mechanisms responsible for the chronicity of the disease and its associated lesions.
Condition  Duodenal Ulcer
Gastric Ulcer
Dyspepsia
Intervention  Procedure: immune response
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  50
Start Date  January 2001
Completion Date October 2001
Eligibility Criteria 

Inclusion Criteria:

  • H. pylori infection

Exclusion Criteria:

  • none
Gender Both
Ages 18 Years to 75 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  Taiwan
Administrative Information Fields
NCT ID  NCT00173953
Organization ID 90M010
Secondary IDs †† 90M010
Study Sponsor  National Taiwan University Hospital
Collaborators ††
Investigators 
Principal Investigator:     Jyh-Chin Yang, M.D.     Department of Internal Medicine, National Taiwan University Hospital    
Information Provided By National Taiwan University Hospital
Verification Date December 2000
First Received Date  September 12, 2005
Last Updated Date September 13, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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