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Lymphocytic Subsets and Cytokine Production With H. Pylori Infection

Primary Purpose

Duodenal Ulcer, Gastric Ulcer, Dyspepsia

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
immune response
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Duodenal Ulcer focused on measuring H. pylori、immune response、lymphocytic subsets、cytokine

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: H. pylori infection Exclusion Criteria: none

Sites / Locations

  • Department of Internal Medicine, National Taiwan University Hospital

Outcomes

Primary Outcome Measures

Cytokines produced by both Th1 / Th2 subsets in gastric antral biopsy specimens from Taiwanese patients before and after anti H. pylori therapy.

Secondary Outcome Measures

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.

Full Information

First Posted
September 12, 2005
Last Updated
September 13, 2005
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00173953
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2000
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2001 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Taiwan University Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Duodenal Ulcer, Gastric Ulcer, Dyspepsia
Keywords
H. pylori、immune response、lymphocytic subsets、cytokine

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
immune response
Primary Outcome Measure Information:
Title
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 Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: H. pylori infection Exclusion Criteria: none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jyh-Chin Yang, M.D.
Organizational Affiliation
Department of Internal Medicine, National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Internal Medicine, National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

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Lymphocytic Subsets and Cytokine Production With H. Pylori Infection

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