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

NCT ID: NCT02933229

Last Updated: 2016-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2031-10-31

Brief Summary

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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

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

biopsy

Intervention Type DEVICE

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

H. pylori eradication

Intervention Type 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.

Interventions

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biopsy

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

Intervention Type DEVICE

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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Yanqing Li

Vice president of Qilu Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Li Yanqing, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital of Shandong University

Locations

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Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, China

Site Status

Countries

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China

Central Contacts

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Li Yanqing, MD, PhD

Role: CONTACT

86-531-82169236

Other Identifiers

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2016SDU-QILU-19

Identifier Type: -

Identifier Source: org_study_id

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