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NCT Number: NCT02933229

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

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

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Li Yanqing, MD, PhD

CONTACT

[email protected]

86-531-82169236

Sponsors and collaborators

Lead sponsor

Shandong University

Other

Registry information

Important dates

Study start
2016
Primary completion
2031
Study completion
2031
First posted
Oct 14, 2016
Registry last updated
Oct 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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