The Associations Between the Gastric Mucosal Pathology and the Eradication Rate of H.Pylori :A Multicenter Study

Use the two-categorical variable , eradicate success or failure ,as a dependent variable, and analyze the influential factors by logistic regression.And then the statistically significant influencing factors like gastric mucosal pathology are obtained.We build a predictive model of the outcome of Hp eradication therapy based on significant influencing factors. The difference with p 0.05 is statistically significant.

Study Overview

• Status: Unknown
• Conditions: Helicobacter Pylori
• Intervention / Treatment: Drug: bismuth-containing quadral therapy based on antibiotic susceptibility

Detailed Description

The subjects who are naiive Hp infection patients recieved the Hp eradication therapy based on antimicrobial susceptibility test.Using success or failure of eradication as a dependent variable, analyze the influential factors by logistic regression.And then the statistically significant influencing factors like gastric mucosal pathology are obtained.We build a predictive model of the outcome of Hp eradication therapy based on significant influencing factors. The difference with p<0.05 is statistically significant.

• Study Type: Interventional
• Enrollment (Anticipated): 1200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tian Ma, MD; Phone Number: 053188369277 18769781098; Email: matian1002@163.com
• Study Contact Backup: Name: Xiuli H Zuo, MD,PhD; Phone Number: 053188369277 15588818685; Email: zuoxiuli@sina.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Recruiting
      • Qilu Hospital of Shandong University
      • Sub-Investigator: Chen Qiao, MD
      • Contact: Xiuli Zuo, MD, PhD; Phone Number: 053188369277 15588818685; Email: zuoxiuli@sina.com
      • Contact: Tian Ma; Phone Number: 18769781098 18769781098; Email: matian1002@163.com

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

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, patient 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?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: the successful group; divide the subject to two groups based on the success or failure of eradication, and analyze the influential factors of eradication. Build a predictive model for the success of eradication.	Drug: bismuth-containing quadral therapy based on antibiotic susceptibility; the different mucosal pathology graded by New Sydney System; Other Names: gastric mucosal pathology
Other: the failure group; divide the subject to two groups based on the success or failure of eradication, and analyze the influential factors of eradication. Build a predictive model for the success of eradication.	Drug: bismuth-containing quadral therapy based on antibiotic susceptibility; the different mucosal pathology graded by New Sydney System; Other Names: gastric mucosal pathology

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eradication Rate of H.Pylori	evaluate the eradication rate of H.Pylori and analysis the association between the gastric mucosal pathology and the eradication rate	2months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Anticipated): September 30, 2020
• Study Completion (Anticipated): September 30, 2020

Study Registration Dates

• First Submitted: July 21, 2019
• First Submitted That Met QC Criteria: July 21, 2019
• First Posted (Actual): July 24, 2019

Study Record Updates

• Last Update Posted (Actual): July 24, 2019
• Last Update Submitted That Met QC Criteria: July 21, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Gastric Mucosal Pathology; Eradication Rate
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Gastrointestinal Agents; Antacids; Anti-Bacterial Agents; Bismuth
• Other Study ID Numbers: 2018SDU-QILU-G113

Drug and device information, study documents

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