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

Helicobacter Pylori Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02933229
• Other study ID #: 2016SDU-QILU-19
• Status: Not yet recruiting
• Phase: Phase 4
• First received: October 11, 2016
• Last updated: October 12, 2016
• Start date: October 2016
• Est. completion date: October 2031

Study information

• Verified date: October 2016
• Source: Shandong University
• Contact: Li Yanqing, MD, PhD
• Phone: 86-531-82169236
• Email: liyanqing[@]sdu.edu.cn
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: October 2031
• Est. primary completion date: October 2031
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Helicobacter Pylori
• Metaplasia
• Operative Link on Gastric Intestinal Assessment
• the Operative Link on Gastric Intestinal Metaplasia

Intervention

Device:
• biopsy
patients enrolled in the study will receive gastroscopy and biopsies in order to evaluate status of pathology.

Drug:
• 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.

Locations

Country	Name	City	State
China	Department of Gastroenterology, Qilu Hospital, Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No