Health TrialsbyHealthPanel

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

ConditionsHelicobacter Pylorithe Operative Link on Gastric Intestinal MetaplasiaOperative Link on Gastric Intestinal Assessment
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-60
SponsorShandong University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with H. pylori infection;

Aged 18-65 years.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • biopsy

    Device

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

  • H. pylori eradication

    Drug

    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.

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: H. pylori eradication cohortExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

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

Time frame
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

Time frame
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

Time frame
15 years

Secondary outcomes

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.

Time frame
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.

Time frame
15 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shandong University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: