The Effact of Helicobacter Hylori Eradication on the Development of Gastric Mucosa Pathology
he Effact of Helicobacter Hylori Eradication on the Development of Gastric Mucosa Pathology
1 other identifier
observational
1,200
1 country
1
Brief Summary
Subjects who are included will recieve Hp eradication therapy based on antimicrobial susceptibility test. After the therapy, the subjects will be divided into two groups, the successful group and the failure group. And then they wiil be followed up to observe the development of the gastric mucosa pathology.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2018
CompletedFirst Submitted
Initial submission to the registry
July 21, 2019
CompletedFirst Posted
Study publicly available on registry
July 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2021
CompletedJuly 23, 2019
July 1, 2019
3.1 years
July 21, 2019
July 21, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
the pathologic status of mucosa
the development or change pathologic status of mucosa
5 years
Secondary Outcomes (3)
PG I
5 years
PG II
5 years
gastrin 17
5 years
Study Arms (2)
the successful eradication cohort
the subjects who eradicate the Hp successfully after recieving the therapy or rescue therapy based on antimicrobial susceptibility test
the failure eradication cohort
the subjects who fail to eradicate the Hp after recieving the therapy or rescue therapy based on antimicrobial susceptibility test
Interventions
the eradication of Hp based on antimicrobial susceptibility test
Eligibility Criteria
Patients, aged between 18 and 70 years old, with positive H. pylori infection that was not eradicated by previous therapies are included.
You may qualify if:
- Patients, aged between 18 and 70 years old, with positive H. pylori infection that was not eradicated by previous therapies are included. The H. pylori infection is confirmed by the positive rapid urease test or 13C-breath test.
You may not qualify if:
- Patients with significant underlying disease including liver, cardiac, pulmonary, and renal diseases, neoplasia, coagulopathy and genetic diseases, history of gastric surgery, pregnancy, breast-feeding, active gastrointestinal bleeding, patients with peptic ulcer, the use of PPI, NSAID or antibiotics during the 4 weeks prior to enrolment, and previous history of allergic reactions to any of the medications used in this protocol. Patients previously treated with H. pylori eradication regimens or those unwilling to participate in the study were also excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Qilu hosipital
Jinan, Shandong, 250012, China
Biospecimen
gastric mucosa
Study Officials
- STUDY CHAIR
Xiuli H Zuo
Qilu Hospital of Shandong University
- PRINCIPAL INVESTIGATOR
Tian H Ma
Qilu Hospital of Shandong University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- director of Qilu Hospital gastroenterology department
Study Record Dates
First Submitted
July 21, 2019
First Posted
July 23, 2019
Study Start
September 1, 2018
Primary Completion
September 30, 2021
Study Completion
September 30, 2021
Last Updated
July 23, 2019
Record last verified: 2019-07