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

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02933229
Enrollment
300
Registered
2016-10-14
Start date
2016-10-31
Completion date
2031-10-31
Last updated
2016-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

Interventions

DEVICEbiopsy

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

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.

Sponsors

Shandong University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
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.

Design outcomes

Primary

MeasureTime frame
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 status15 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 status15 years
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 status15 years

Secondary

MeasureTime frame
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

Countries

China

Contacts

Primary ContactLi Yanqing, MD, PhD
liyanqing@sdu.edu.cn86-531-82169236

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026