- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00173953
Lymphocytic Subsets and Cytokine Production With H. Pylori Infection
September 13, 2005 updated by: National Taiwan University Hospital
Lymphocytic Subsets and Cytokine Production in the Gastric Samples of Patients With Helicobacter Pylori Infection
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 Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Taipei, Taiwan, 100
- Department of Internal Medicine, National Taiwan University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- H. pylori infection
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Cytokines produced by both Th1 / Th2 subsets in gastric antral biopsy specimens from Taiwanese patients before and after anti H. pylori therapy.
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Secondary Outcome Measures
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jyh-Chin Yang, M.D., Department of Internal Medicine, National Taiwan University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2001
Study Completion
October 1, 2001
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 15, 2005
Study Record Updates
Last Update Posted (Estimate)
September 15, 2005
Last Update Submitted That Met QC Criteria
September 13, 2005
Last Verified
December 1, 2000
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 90M010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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