Helicobacter GastritisNCT00275886
Activation and Recruitment of GIL During Hp Infection
An observational study of Helicobacter Gastritis and Dyspepsia, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Helicobacter pylori is a major human pathogen that infects over half of the world population. Infection initiates a series of changes in the gastric mucosa, beginning with gastritis and leading in some patients to peptic ulcer disease, mucosa-associated lymphomas, and gastric adenocarcinoma. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Helicobacter Gastritis, Dyspepsia
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2006to Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients receiveing endoscopy examination due to dyspepsia
Who cannot join
- nil
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Ping-Ning Hsu, MD, PhD, +886-223123456 ext. 8635, phsu@ha.mc.ntu.edu.tw
Ping-Ning Hsu, MD, PhD
About this study
Official title: Activation and Recruitment of Gastric Infiltrating Lymphocytes During H. Pylori Infection
Helicobacter pylori is a major human pathogen that infects over half of the world population. Infection initiates a series of changes in the gastric mucosa, beginning with gastritis and leading in some patients to peptic ulcer disease, mucosa-associated lymphomas, and gastric adenocarcinoma. It is believed that host factors, in particular, the T cell-mediated immune responses may play an important role in the pathogenesis of diseases induced by H. pylori infection. Recent results revealed that there were higher IFN-γ secreting cells in gastric infiltrating T cells isolated from H. pylori infected patients than in uninfected patients, suggesting that the TH1 response and degree of IFN-γ production is associated with disease severity. Meanwhile, recent studies have shown that apoptosis of the gastric epithelium is increased during infection and this response is associated with an expansion of gastric T-helper type 1 (Th1) cells. In this project, we are trying to further investigate role of host T cell mediated immune response in pathogenesis of Helicobacter infection by characterization of the expression of chemokine receptors on gastric infiltrating lymphocytes. We are going to investigate the mechanisms involving in chemokine/chemokine receptor interaction in recruitment of gastric infiltrating lymphocytes and pathogenesis of gastric mucosa damage in Helicobacter infection. This study will be helpful for understanding the mechanisms of activation and recruitment of gastric-infiltrating lymphocytes during gastric inflammation.
Read the detailed description
Specific Aim #1: Characterization of the gastric infiltrating T cells from H. pylori gastritis patients A. Patients H. pylori infected gastritis and asymptomatic patients are selected from National Taiwan University hospital. The gastric biopsy specimen are taken from endoscopic biopsy in routine health check up or panendoscopic examination for the despeptic patients. HP negative gastritis patients will also be studied for negative control.
- Immunohistochemical identification of T cells and expression of chemokine receptors.
Specific Aim #2 . Isolation and characterization of chemokines and chemokine receptors of the infiltrating lymphocytes in H. pylori-associated gastritis tissue
- Isolation of gastric infiltrating lymphocyte B. Identification of the expression of chemokine receptor in gastric infiltrating lymphocytes by flow cytometry C. Detection of expression of chemokines in gastric tissues
- Conditions
- Helicobacter Gastritis, Dyspepsia
- Medical subject headings
- Dyspepsia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2006 (estimated)
- Study startJan 2006
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter GastritisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ping-Ning Hsu, MD, PhD, Principal investigator, Department of Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00275886
- Sponsor's protocol ID
- 9461701221
- Status last verified
- Dec 2005
- First submitted
- 11 Jan 2006
- Last updated
- 12 Jan 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activation and Recruitment of Gastric Infiltrating Lymphocytes During H. Pylori Infection
- ClinicalTrials.gov ID
- NCT00275886
- Acronym / sponsor ID
- 9461701221
- Conditions
- Helicobacter Gastritis, Dyspepsia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2006
- Study completion
- Dec 2008
- First posted
- 12 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Helicobacter pylori is a major human pathogen that infects over half of the world population. Infection initiates a series of changes in the gastric mucosa, beginning with gastritis and leading in some patients to peptic ulcer disease, mucosa-associated lymphomas, and gastric adenocarcinoma. It is believed that host factors, in particular, the T cell-mediated immune responses may play an important role in the pathogenesis of diseases induced by H. pylori infection. Recent results revealed that there were higher IFN-γ secreting cells in gastric infiltrating T cells isolated from H. pylori infected patients than in uninfected patients, suggesting that the TH1 response and degree of IFN-γ production is associated with disease severity. Meanwhile, recent studies have shown that apoptosis of the gastric epithelium is increased during infection and this response is associated with an expansion of gastric T-helper type 1 (Th1) cells. In this project, we are trying to further investigate role of host T cell mediated immune response in pathogenesis of Helicobacter infection by characterization of the expression of chemokine receptors on gastric infiltrating lymphocytes. We are going to investigate the mechanisms involving in chemokine/chemokine receptor interaction in recruitment of gastric infiltrating lymphocytes and pathogenesis of gastric mucosa damage in Helicobacter infection. This study will be helpful for understanding the mechanisms of activation and recruitment of gastric-infiltrating lymphocytes during gastric inflammation.
Detailed description
Specific Aim #1: Characterization of the gastric infiltrating T cells from H. pylori gastritis patients A. Patients H. pylori infected gastritis and asymptomatic patients are selected from National Taiwan University hospital. The gastric biopsy specimen are taken from endoscopic biopsy in routine health check up or panendoscopic examination for the despeptic patients. HP negative gastritis patients will also be studied for negative control.
- Immunohistochemical identification of T cells and expression of chemokine receptors.
Specific Aim #2 . Isolation and characterization of chemokines and chemokine receptors of the infiltrating lymphocytes in H. pylori-associated gastritis tissue
- Isolation of gastric infiltrating lymphocyte B. Identification of the expression of chemokine receptor in gastric infiltrating lymphocytes by flow cytometry C. Detection of expression of chemokines in gastric tissues
Study design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients receiveing endoscopy examination due to dyspepsia
Key exclusion criteria (1 listed)
- nil
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ping-Ning Hsu, MD, PhD principal investigator
Department of Immunology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Helicobacter Gastritis and Dyspepsia, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ping-Ning Hsu, MD, PhD (886-2-23123456 ext. 8635, phsu@ha.mc.ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2006.