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

Helicobacter Pylori Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04030715
• Other study ID #: 2018SDU-QILU-G113
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: September 30, 2020

Study information

• Verified date: July 2019
• Source: Shandong University
• Contact: Xiuli H Zuo, MD,PhD
• Phone: 15588818685
• Email: zuoxiuli[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Helicobacter Pylori

Intervention

Drug:
• bismuth-containing quadral therapy based on antibiotic susceptibility
the different mucosal pathology graded by New Sydney System

Locations

Country	Name	City	State
China	Qilu Hospital of Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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