NCT02933229|Not Yet RecruitingPhase 4DMC
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Sponsor study identifier
interventional
300
1 country
1
Study Start
October 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2016
Date type not reportedThis date has not been verified as actual or estimated.
October 11, 2016
Actual (reported)October 14, 2016
Actual (reported)October 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
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
15 years
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.
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.
15 years
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.
patients enrolled in the study will receive gastroscopy and biopsies in order to evaluate status of pathology.
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.
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, 250012, China
Li Yanqing, MD, PhD
Qilu Hospital of Shandong University
First Submitted
October 11, 2016
First Posted
October 14, 2016
Study Start
October 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2031
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 14, 2016
Record last verified: 2016-10
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Source: ClinicalTrials.gov.
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