Lymphocytic Subsets and Cytokine Production With H. Pylori Infection

This study has been completed.
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00173953
First received: September 12, 2005
Last updated: September 13, 2005
Last verified: December 2000
  Purpose

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.


Condition Intervention
Duodenal Ulcer
Gastric Ulcer
Dyspepsia
Procedure: immune response

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Lymphocytic Subsets and Cytokine Production in the Gastric Samples of Patients With Helicobacter Pylori Infection

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

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.

Estimated Enrollment: 50
Study Start Date: January 2001
Estimated Study Completion Date: October 2001
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • H. pylori infection

Exclusion Criteria:

  • none
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00173953

Locations
Taiwan
Department of Internal Medicine, National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Jyh-Chin Yang, M.D. Department of Internal Medicine, National Taiwan University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00173953     History of Changes
Other Study ID Numbers: 90M010, 90M010
Study First Received: September 12, 2005
Last Updated: September 13, 2005
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
H. pylori、immune response、lymphocytic subsets、cytokine

Additional relevant MeSH terms:
Ulcer
Stomach Ulcer
Duodenal Ulcer
Pathologic Processes
Peptic Ulcer
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Duodenal Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on September 16, 2014