Back to resultsThe Influence of Helicobacter Pylori Eradication on Gastric Pathology: a Long-term, Prospective Cohort Study
Primary Purpose
Helicobacter Pylori, the Operative Link on Gastric Intestinal Metaplasia, Operative Link on Gastric Intestinal Assessment
Status
Not yet recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
biopsy
H. pylori eradication
Sponsored by
About this trial
This is an interventional prevention trial for Helicobacter Pylori
Eligibility Criteria
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.
Sites / Locations
- Department of Gastroenterology, Qilu Hospital, Shandong University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
H. pylori eradication cohort
Arm 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.
Outcomes
Primary Outcome Measures
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
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
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
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02933229
Brief Title
The Influence of Helicobacter Pylori Eradication on Gastric Pathology: a Long-term, Prospective Cohort Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2016 (undefined)
Primary Completion Date
October 2031 (Anticipated)
Study Completion Date
October 2031 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong University
4. Oversight
Data Monitoring Committee
Yes
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori, the Operative Link on Gastric Intestinal Metaplasia, Operative Link on Gastric Intestinal Assessment
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
H. pylori eradication cohort
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
biopsy
Intervention Description
patients enrolled in the study will receive gastroscopy and biopsies in order to evaluate status of pathology.
Intervention Type
Drug
Intervention Name(s)
H. pylori eradication
Intervention 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.
Primary Outcome Measure Information:
Title
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
Time Frame
15 years
Title
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
Time Frame
15 years
Title
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
Time Frame
15 years
Secondary Outcome Measure Information:
Title
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.
Time Frame
15 years
Title
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.
Time Frame
15 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Yanqing, MD, PhD
Phone
86-531-82169236
Email
liyanqing@sdu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Yanqing, MD, PhD
Organizational Affiliation
Qilu Hospital of Shandong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Gastroenterology, Qilu Hospital, Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Influence of Helicobacter Pylori Eradication on Gastric Pathology: a Long-term, Prospective Cohort Study
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