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

• Conditions: Helicobacter Gastritis
• Interventions: Other: the eradication Hp

• Registration Number: NCT04029441
• Lead Sponsor: Shandong University

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.

Detailed Description

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.

Study Timeline

• Study Start: 2018-09-01
• Status Verified: 2019-07
• Study First Submitted: 2019-07-21
• Study First Submitted QC: 2019-07-21
• Last Update Submitted: 2019-07-21
• Study First Posted: 2019-07-23
• Last Update Posted: 2019-07-23
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
the successful eradication cohort	the eradication Hp	the subjects who eradicate the Hp successfully after recieving the therapy or rescue therapy based on antimicrobial susceptibility test

Primary Outcome Measures

Name	Time	Method
the pathologic status of mucosa	5 years	the development or change pathologic status of mucosa

Secondary Outcome Measures

Name	Time	Method
PG I	5 years	the serum level of PG I
PG II	5 years	the serum level of PG II
gastrin 17	5 years	the serum level of gastrin 17

Trial Locations

Locations (1)

Qilu hosipital; 🇨🇳 Jinan, Shandong, China