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

Shandong University

Status and phase: Not yet enrolling; Phase 4

Conditions: Operative Link on Gastric Intestinal Assessment; Helicobacter Pylori; the Operative Link on Gastric Intestinal Metaplasia

Treatments: Drug: H. pylori eradication; Device: biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT02933229

2016SDU-QILU-19

Details and patient eligibility

About

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

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

H. pylori eradication cohort

Experimental group

Description:

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.

Treatment:

Device: biopsy

Drug: H. pylori eradication