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

Phase 4

Not yet recruiting

• Conditions: Helicobacter Pylori; Operative Link on Gastric Intestinal Assessment; the Operative Link on Gastric Intestinal Metaplasia
• Interventions: Device: biopsy; Drug: H. pylori eradication

• Registration Number: NCT02933229
• Lead Sponsor: Shandong University

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-10
• Study Start: 2016-10
• Study First Submitted: 2016-10-11
• Study First Submitted QC: 2016-10-12
• Last Update Submitted: 2016-10-12
• Study First Posted: 2016-10-14
• Last Update Posted: 2016-10-14
• Primary Completion: 2031-10
• Study Completion: 2031-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
H. pylori eradication cohort	biopsy	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.
H. pylori eradication cohort	H. pylori eradication	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.

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Gastroenterology, Qilu Hospital, Shandong University; 🇨🇳 Jinan, Shandong, China