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Not yet recruiting NCT02933229

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

Phase IV Interventional Helicobacter Pylori the Operative Link on Gastric Intestinal Metaplasia Operative Link on Gastric Intestinal Assessment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: biopsy, H. pylori eradication.
Who it may be relevant to
Registry conditions: Helicobacter Pylori, the Operative Link on Gastric Intestinal Metaplasia, Operative Link on Gastric Intestinal Assessment. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • 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.

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 [Time frame: 15 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 status [Time frame: 15 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 status [Time frame: 15 years]
Secondary outcome measures (2)
  • 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]
  • 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

China · 1 center
  • Department of Gastroenterology, Qilu Hospital, Shandong University — Jinan

Identifiers

NCT: NCT02933229 · 2016SDU-QILU-19

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗