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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. |
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| 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. |
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| 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 |
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| Intervention † | Procedure: immune response | ||||
| MEDLINE PMIDs | |||||
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| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 50 | ||||
| Start Date † | January 2001 | ||||
| Completion Date | October 2001 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| 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 † |
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| Information Provided By | National Taiwan University Hospital | ||||
| Verification Date | December 2000 | ||||
| First Received Date † | September 12, 2005 | ||||
| Last Updated Date | September 13, 2005 | ||||