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

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ClinicalTrials.gov Identifier: NCT02933229
Recruitment Status : Not yet recruiting
First Posted : October 14, 2016
Last Update Posted : October 14, 2016
Sponsor:
Information provided by (Responsible Party):
Yanqing Li, Shandong University

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

Condition or disease Intervention/treatment Phase
Helicobacter Pylori the Operative Link on Gastric Intestinal Metaplasia Operative Link on Gastric Intestinal Assessment Device: biopsy Drug: H. pylori eradication Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : October 2016
Estimated Primary Completion Date : October 2031
Estimated Study Completion Date : October 2031

Arm Intervention/treatment
Experimental: 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.

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 :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02933229


Contacts
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Contact: Li Yanqing, MD, PhD 86-531-82169236 liyanqing@sdu.edu.cn

Locations
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China, Shandong
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, China, 250012
Sponsors and Collaborators
Shandong University
Investigators
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Principal Investigator: Li Yanqing, MD, PhD Qilu Hospital of Shandong University

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Responsible Party: Yanqing Li, Vice president of Qilu Hospital, Shandong University
ClinicalTrials.gov Identifier: NCT02933229     History of Changes
Other Study ID Numbers: 2016SDU-QILU-19
First Posted: October 14, 2016    Key Record Dates
Last Update Posted: October 14, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Metaplasia
Pathologic Processes