The Effact of Helicobacter Hylori Eradication on the Development of Gastric Mucosa Pathology

NCT ID: NCT04029441

Last Updated: 2019-07-23

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

UNKNOWN

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-01

Study Completion Date

2021-09-30

Brief Summary

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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.

Detailed Description

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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. The subjects who fail to eradicate the Hp after initial treatment and rescue treatment will go into the failure group. Otherwhile, they will go to the successful group.And then they wiil be followed up to observe the development of the gastric mucosa pathology. For mild atrophy gastritis, non- intestinal metaplasial gastritis, follow-up is performed every 2-3 years.For severe atrophy gastritis, intestinal metaplasial gastritis, follow-up is performed every 1-2 years. For patients wth high-grade intraepithelial neoplasia, they can be included 3 months after the endoscopic treatment, and the follow up will be performed at 6, 12 months after the treatment and then the follow up will be carried out every 1 year. For non-atrophic gastritis, no follow-up will be performed. All included patients will recieve a follow-up at the endpoint of 5 years. The follow-up includes endoscopy examination and serum test of PG I,PG II and gastrin 17.

Conditions

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Helicobacter Gastritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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the successful eradication cohort

the subjects who eradicate the Hp successfully after recieving the therapy or rescue therapy based on antimicrobial susceptibility test

the eradication Hp

Intervention Type OTHER

the eradication of Hp 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

No interventions assigned to this group

Interventions

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the eradication Hp

the eradication of Hp based on antimicrobial susceptibility test

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 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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Xiuli Zuo

director of Qilu Hospital gastroenterology department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiuli H Zuo

Role: STUDY_CHAIR

Qilu Hospital of Shandong University

Tian H Ma

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital of Shandong University

Locations

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Qilu hosipital

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiuli H Zuo, MD,PhD

Role: CONTACT

15588818685 ext. 053188369277

Tian H Ma, MD

Role: CONTACT

18769781098 ext. 053188369277

Facility Contacts

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Xiuli H Zuo, MD,PhD

Role: primary

15588818685 ext. 0531-88369277

Tian H Ma

Role: backup

18769781098 ext. 0531-88369277

Other Identifiers

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2018SDU-QILU-G115

Identifier Type: -

Identifier Source: org_study_id

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