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

• Sponsor: Shandong University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT02933229
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Arm: 1
• Duration (Months): 180
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori; the Operative Link on Gastric Intestinal Metaplasia; Operative Link on Gastric Intestinal Assessment	Device: biopsy; Drug: H. pylori eradication	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 300 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Study Start Date: Oct 1, 2016
• Anticipated Primary Completion Date: Oct 1, 2031
• Anticipated Study Completion Date: Oct 1, 2031

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.

Outcome Measures

Primary Outcome Measures

1. 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]

2. 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]

3. 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

1. 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]

2. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Gastroenterology, Qilu Hospital, Shandong University	Jinan	Shandong	China	250012

Sponsors and Collaborators

• Shandong University

Investigators

• Principal Investigator: Li Yanqing, MD, PhD, Qilu Hospital of Shandong University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yanqing Li, Vice president of Qilu Hospital, Shandong University
• ClinicalTrials.gov Identifier: NCT02933229
• Other Study ID Numbers: 2016SDU-QILU-19
• First Posted: Oct 14, 2016
• Last Update Posted: Oct 14, 2016
• Last Verified: Oct 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Metaplasia

Study Results

No Results Posted as of Oct 14, 2016