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

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.

Study Overview

• Status: Unknown
• Conditions: Helicobacter Gastritis
• Intervention / Treatment: Other: the eradication Hp

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 Type: Observational
• Enrollment (Anticipated): 1200

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Recruiting
      • Qilu hosipital
      • Contact: Xiuli H Zuo, MD,PhD; Phone Number: 0531-88369277 15588818685; Email: zuoxiuli@sdu.edu.cn
      • Contact: Tian H Ma; Phone Number: 0531-88369277 18769781098; Email: matian1002@163.com
      • Sub-Investigator: Chen H Qiao
      • Sub-Investigator: Junnan Hu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients, aged between 18 and 70 years old, with positive H. pylori infection that was not eradicated by previous therapies are included.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
the successful eradication cohort; the subjects who eradicate the Hp successfully after recieving the therapy or rescue therapy based on antimicrobial susceptibility test	Other: the eradication Hp; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the pathologic status of mucosa	the development or change pathologic status of mucosa	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PG I	the serum level of PG I	5 years
PG II	the serum level of PG II	5 years
gastrin 17	the serum level of gastrin 17	5 years

Collaborators and Investigators

• Sponsor: Shandong University
• Investigators: Study Chair: Xiuli H Zuo, Qilu Hospital of Shandong University; Principal Investigator: Tian H Ma, Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Anticipated): September 30, 2021
• Study Completion (Anticipated): September 30, 2021

Study Registration Dates

• First Submitted: July 21, 2019
• First Submitted That Met QC Criteria: July 21, 2019
• First Posted (Actual): July 23, 2019

Study Record Updates

• Last Update Posted (Actual): July 23, 2019
• Last Update Submitted That Met QC Criteria: July 21, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Gastritis
• Other Study ID Numbers: 2018SDU-QILU-G115

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No