The Influence of Helicobacter Pylori Eradication on Gastric Pathology: a Long-term, Prospective Cohort Study

Study Overview
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Brief Summary
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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

Conditions
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Helicobacter Pylori, the Operative Link on Gastric Intestinal Metaplasia, Operative Link on Gastric Intestinal Assessment

Intervention / Treatment
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* Device: biopsy
* Drug: H. pylori eradication


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: H. pylori eradication cohort<br>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. | Device: biopsy<br>* patients enrolled in the study will receive gastroscopy and biopsies in order to evaluate status of pathology.<br>Drug: H. pylori eradication<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 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 |  | 15 years | 
| 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 |  | 15 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |