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

• Sponsor: Shandong University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04030715
• Collaborator: (none)
• Enrollment: 1,200
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 25
• Patients Per Site Per Month: 48.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori	Drug: bismuth-containing quadral therapy based on antibiotic susceptibility	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 1200 participants
• Allocation: Non-Randomized
• Intervention Model: Factorial Assignment
• 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.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.
• Masking: None (Open Label)
• Masking Description: no masking
• Primary Purpose: Other
• Official Title: The Associations Between the Gastric Mucosal Pathology and the Eradication Rate of H.Pylori :A Multicenter Study
• Actual Study Start Date: Sep 1, 2018
• Anticipated Primary Completion Date: Sep 30, 2020
• Anticipated Study Completion Date: Sep 30, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Eradication Rate of H.Pylori [2months]

   evaluate the eradication rate of H.Pylori and analysis the association between the gastric mucosal pathology and the eradication rate

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Qilu Hospital of Shandong University	Jinan	Shandong	China	250012

Sponsors and Collaborators

• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xiuli Zuo, director of Qilu Hospital gastroenterology department, Shandong University
• ClinicalTrials.gov Identifier: NCT04030715
• Other Study ID Numbers: 2018SDU-QILU-G113
• First Posted: Jul 24, 2019
• Last Update Posted: Jul 24, 2019
• Last Verified: Jul 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Xiuli Zuo, director of Qilu Hospital gastroenterology department, Shandong University: Gastric Mucosal Pathology; Eradication Rate
• Additional relevant MeSH terms: Anti-Bacterial Agents; Bismuth

Study Results

No Results Posted as of Jul 24, 2019