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

NCT04030715 | Unknown DMC

• 1 other identifier: 2018SDU-QILU-G113
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Helicobacter Pylori

Keywords

Gastric Mucosal Pathology; Eradication Rate

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

the successful group

OTHER

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 failure group

OTHER

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

Interventions

bismuth-containing quadral therapy based on antibiotic susceptibility DRUG

the different mucosal pathology graded by New Sydney System

Also known as: gastric mucosal pathology

the failure group; the successful group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Study Officials

• Xiuli Zuo, MD,PhD

  Qilu Hospital of Shandong University

  STUDY CHAIR

• Tian Ma, MD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiuli H Zuo, MD,PhD

CONTACT

15588818685; zuoxiuli@sina.com

Tian Ma, MD

CONTACT

18769781098; matian1002@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: no masking
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of Qilu Hospital gastroenterology department

Model Details: 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 Record Dates

• First Submitted: July 21, 2019
• First Posted: July 24, 2019
• Study Start: September 1, 2018
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: July 24, 2019

Record last verified: 2019-07

Locations

CN (1)