Lymphocytic Subsets and Cytokine Production With H. Pylori Infection
| Tracking Information | |||||
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| First Received Date ICMJE | September 12, 2005 | ||||
| Last Updated Date | September 13, 2005 | ||||
| Start Date ICMJE | January 2001 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Cytokines produced by both Th1 / Th2 subsets in gastric antral biopsy specimens from Taiwanese patients before and after anti H. pylori therapy. | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00173953 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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. | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Lymphocytic Subsets and Cytokine Production With H. Pylori Infection | ||||
| Official Title ICMJE | 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 Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: immune response | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 50 | ||||
| Completion Date | October 2001 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Taiwan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00173953 | ||||
| Other Study ID Numbers ICMJE | 90M010, 90M010 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | National Taiwan University Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | National Taiwan University Hospital | ||||
| Verification Date | December 2000 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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