Clinical trial NCT04030715: The Associations Between the Gastric Mucosal Pathology and the Eradication Rate of H.Pylori :A Multicenter Study
Official title: The Associations Between the Gastric Mucosal Pathology and the Eradication Rate of H.Pylori :A Multicenter Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Helicobacter Pylori
Keywords: Gastric Mucosal Pathology
Eradication Rate
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2019-07-24
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 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.
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Eradication Rate of H.Pylori
timeFrame: 2months
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Xiuli Zuo, MD,PhD
role: STUDY_CHAIR
affiliation: Qilu Hospital of Shandong University
name: Tian Ma, MD
role: PRINCIPAL_INVESTIGATOR
References: