The Influence of Helicobacter Pylori Eradication on Gastric Pathology: a Long-term, Prospective Cohort Study
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- The proportion of more severe IM in the gastric mucosa for 15 years after H. pylori eradication at five points of the stomach compared with original status
Study Overview
Brief Summary
Helicobacter pylori (H. pylori) infection, affecting an estimated 50% of the global population, is a main cause of chronic gastritis, peptic ulcers and gastric cancer. By causing progressive damage to the stomach and may eventually result in gastric atrophy, H. pylori infection has been demonstrated to be responsible for more than 95% of gastric malignancies
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with H. pylori infection;
- •Aged 18-65 years.
Exclusion Criteria
- •Patients with gastrectomy, acute GI bleeding and advanced gastric cancer;
- •Conditions unsuitable for performance of gastroscopy, such as coagulopathy, impaired renal function;
- •Pregnancy or breastfeeding;
- •Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.
Arms & Interventions
H. pylori eradication cohort
H. pylori eradication therapy comprising esomeprazole, amoxicillin,clarithromycin and colloidal bismuth pectin.
If failed in eradicating H. pylori, a culture based antimicrobial susceptibility test will be used to guide H. pylori eradication.
Intervention: biopsy (Device)
H. pylori eradication cohort
H. pylori eradication therapy comprising esomeprazole, amoxicillin,clarithromycin and colloidal bismuth pectin.
If failed in eradicating H. pylori, a culture based antimicrobial susceptibility test will be used to guide H. pylori eradication.
Intervention: H. pylori eradication (Drug)
Outcomes
Primary Outcomes
The proportion of more severe IM in the gastric mucosa for 15 years after H. pylori eradication at five points of the stomach compared with original status
Time Frame: 15 years
The proportion of more severe inflammation in the gastric mucosa for 15 years after H. pylori eradication at five points of the stomach compared with original status
Time Frame: 15 years
The proportion of more severe atrophy in the gastric mucosa for 15 years after H. pylori eradication at five points of the stomach compared with original status
Time Frame: 15 years
Secondary Outcomes
- The proportion of more advanced stages for 15 years after H. pylori eradication by using operative link on gastritis assessment (OLGA) system compared with original status.(15 years)
- The proportion of more advanced stages for 15 years after H. pylori eradication by using operative link for gastritis intestinal metaplasia (OLGIM) system compared with original status.(15 years)
Investigators
Yanqing Li
Vice president of Qilu Hospital
Shandong University