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

Shandong University

Status: Unknown

Conditions: Helicobacter Pylori

Treatments: Drug: bismuth-containing quadral therapy based on antibiotic susceptibility

Study type: Interventional

Funder types: Other

Identifiers

NCT04030715

2018SDU-QILU-G113

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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1,200 participants in 2 patient groups

the successful group

Other group

Description:

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.

Treatment:

Drug: bismuth-containing quadral therapy based on antibiotic susceptibility

the failure group

Other group

Description:

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.

Treatment:

Drug: bismuth-containing quadral therapy based on antibiotic susceptibility