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Influencing Factors of Helicobacter Pylori Infection and Eradication Failure

Primary Purpose

Helicobacter Pylori Infection

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PPI quadruple therapy
Sponsored by
Second Affiliated Hospital of Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Helicobacter Pylori Infection focused on measuring Helicobacter pylori, Infection, Risk Factor, Questionnaire

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Perform 13-UBT,
  2. Be able to understand the content of the questionnaire and answer the questions accurately,
  3. Permanent residents of Xi'an area,
  4. No previous HP eradication treatment,
  5. Agree to join the group and sign the informed consent form,
  6. Aged between 18-70.

Exclusion Criteria:

  1. Complicated with serious cardiovascular, respiratory, blood, liver, kidney, nerve or endocrine system diseases,
  2. Mental disease,
  3. Gastric or esophageal surgery history,
  4. Severe atypical hyperplasia of gastric epithelium, gastric malignant tumor or other malignant diseases
  5. Pregnant or lactating women,
  6. Patients with history of penicillin allergy,
  7. Allergy to rabeprazole, bismuth dose, clindamycin,
  8. Have taken proton pump inhibitors,H2 receptor antagonists, within 2 weeks before participating in the inspection,
  9. Have taken herbs that have bacteriostatic effect or antibiotic or bismuth agents within 4 weeks before participating in the inspection.

Sites / Locations

  • The second affiliated hospital of Xi'an Jiaotong universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Other

Other

Arm Label

H. pylori negative group

H. pylori positive and successful eradication group

H. pylori positive and eradication failure group

Arm Description

No Intervention

H. pylori-positive patients are given rabeprazole 10mg + amoxicillin 1000mg + clarithromycin 500mg + colloidal bismuth tartrate 220mg bid for 14 days. After 4-6 weeks of completing eradication therapy, 13C-UBT is performed and the result show that H. pylori is eradicated. At the same time, Patients with successful eradication are instructed to conduct 13C-UBT examination after 6 months,1year and every year after drug withdrawal.

H. pylori-positive patients are given rabeprazole 10mg + amoxicillin 1000mg + clarithromycin 500mg + colloidal bismuth tartrate 220mg bid for 14 days. After 4-6 weeks of completing eradication therapy, 13C-UBT is performed and the result show that H. pylori is not eradicated.

Outcomes

Primary Outcome Measures

Infection rate
The infection rate is defined as the proportion of patients diagnosed positive among all subjects undergoing 13-UBT.(On the 13-UBT,if the result DOB≥4. 0‰, it can be determined that the subject is H. pylori positive; DOB <4. 0‰,the subject is H. pylori negative)
The Affecting factors of Helicobacter pylori infection is investigated by questionnaire statistics.
The questionnaire refers to "National Helicobacter pylori Research Questionnaire", which is designed by the Department of Epidemiology and Health Statistics, Peking University School of Medicine.And the questionnaire includes general situation, basic situation, living environment and living habits, personal disease history, related symptoms,and family history, etc.Through logistic regression analysis to calculate OR value and P value, to understand the relationship between Helicobacter pylori infection and the factors involved in the questionnaire.
Eradication rate
H. pylori-positive patients are given PPI quadruple therapy,and after 4-6 weeks of completing eradication therapy, 13C-UBT is performed.Eradication rate is defined as the ratio of the number of subjects who become negative after taking the eradication drug to the number of all subjects who take the eradication drug.
The Affecting factors of Helicobacter pylori eradication failure is investigated by questionnaire statistics.
The questionnaire refers to "National Helicobacter pylori Research Questionnaire", which is designed by the Department of Epidemiology and Health Statistics, Peking University School of Medicine.And the questionnaire includes general situation, basic situation, living environment and living habits, personal disease history, related symptoms,and family history, etc.Through logistic regression analysis to calculate OR value and P value, to understand the relationship between Helicobacter pylori eradication failure and the factors involved in the questionnaire.

Secondary Outcome Measures

Full Information

First Posted
January 8, 2022
Last Updated
February 6, 2022
Sponsor
Second Affiliated Hospital of Xi'an Jiaotong University
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1. Study Identification

Unique Protocol Identification Number
NCT05226819
Brief Title
Influencing Factors of Helicobacter Pylori Infection and Eradication Failure
Official Title
Analysis of Influencing Factors of Helicobacter Pylori Infection and Eradication Failure in Outpatients of Digestive Department in Xi'an
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 6, 2022 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital of Xi'an Jiaotong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Helicobacter pylori (H. pylori) is closely related to the occurrence of gastric cancer and other diseases, the discovery and eradication of H. pylori infection has great significance to the prevention and treatment of related diseases. At the same time,understanding the influencing factors of H. pylori infection and eradication failure in the population can provide a scientific basis for the formulation of local H. pylori prevention and control strategies. So, the investigators intend to analyze the factors related to H. pylori infection and eradication failure in the outpatients of gastroenterology clinics in Xi'an, China.
Detailed Description
Taking 300 permanent residents in Xi'an area who will go to the Gastroenterology Clinic of the Second Affiliated Hospital of Xi'an Jiaotong University from February 2022 to March 2023 and undergo 13C-UBT examination as the research object. A questionnaire survey on factors related to H. pylori infection and eradication failure will be conducted. The questionnaire includes basic Information, eating patterns, living environment, related gastrointestinal symptoms, etc. Among the outpatients, H. pylori-positive patients will be given rabeprazole 10 mg + amoxicillin 1000 mg + clarithromycin 500 mg + colloidal bismuth tartrate 220 mg bid for 14 days. After 4-6 weeks of completing eradication therapy, 13C-UBT will be performed to determine whether H. pylori is eradicated. According to the results of 13C-UBT at the beginning and results of 13C-UBT after eradication treatment, outpatients will be divided into three groups: H. pylori negative group, H. pylori positive radical cure successful group and H. pylori positive radical cure failed group. Next using SPSS 19.0 Statistical software analyzes H. pylori infection and eradication failure related influencing factors. According to the analysis, the investigators can provide a scientific basis for local formulation of correct and effective H. pylori prevention and control strategies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection
Keywords
Helicobacter pylori, Infection, Risk Factor, Questionnaire

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
H. pylori negative group
Arm Type
No Intervention
Arm Description
No Intervention
Arm Title
H. pylori positive and successful eradication group
Arm Type
Other
Arm Description
H. pylori-positive patients are given rabeprazole 10mg + amoxicillin 1000mg + clarithromycin 500mg + colloidal bismuth tartrate 220mg bid for 14 days. After 4-6 weeks of completing eradication therapy, 13C-UBT is performed and the result show that H. pylori is eradicated. At the same time, Patients with successful eradication are instructed to conduct 13C-UBT examination after 6 months,1year and every year after drug withdrawal.
Arm Title
H. pylori positive and eradication failure group
Arm Type
Other
Arm Description
H. pylori-positive patients are given rabeprazole 10mg + amoxicillin 1000mg + clarithromycin 500mg + colloidal bismuth tartrate 220mg bid for 14 days. After 4-6 weeks of completing eradication therapy, 13C-UBT is performed and the result show that H. pylori is not eradicated.
Intervention Type
Drug
Intervention Name(s)
PPI quadruple therapy
Intervention Description
Among these outpatients, H. pylori-negative patients don't give any intervention. But H. pylori-positive patients are given rabeprazole 10mg + amoxicillin 1000mg + clarithromycin 500mg + colloidal bismuth tartrate 220mg bid for 14 days. After 4-6 weeks of completing eradication therapy, 13C-UBT is performed.
Primary Outcome Measure Information:
Title
Infection rate
Description
The infection rate is defined as the proportion of patients diagnosed positive among all subjects undergoing 13-UBT.(On the 13-UBT,if the result DOB≥4. 0‰, it can be determined that the subject is H. pylori positive; DOB <4. 0‰,the subject is H. pylori negative)
Time Frame
1 year
Title
The Affecting factors of Helicobacter pylori infection is investigated by questionnaire statistics.
Description
The questionnaire refers to "National Helicobacter pylori Research Questionnaire", which is designed by the Department of Epidemiology and Health Statistics, Peking University School of Medicine.And the questionnaire includes general situation, basic situation, living environment and living habits, personal disease history, related symptoms,and family history, etc.Through logistic regression analysis to calculate OR value and P value, to understand the relationship between Helicobacter pylori infection and the factors involved in the questionnaire.
Time Frame
1 year
Title
Eradication rate
Description
H. pylori-positive patients are given PPI quadruple therapy,and after 4-6 weeks of completing eradication therapy, 13C-UBT is performed.Eradication rate is defined as the ratio of the number of subjects who become negative after taking the eradication drug to the number of all subjects who take the eradication drug.
Time Frame
1 year
Title
The Affecting factors of Helicobacter pylori eradication failure is investigated by questionnaire statistics.
Description
The questionnaire refers to "National Helicobacter pylori Research Questionnaire", which is designed by the Department of Epidemiology and Health Statistics, Peking University School of Medicine.And the questionnaire includes general situation, basic situation, living environment and living habits, personal disease history, related symptoms,and family history, etc.Through logistic regression analysis to calculate OR value and P value, to understand the relationship between Helicobacter pylori eradication failure and the factors involved in the questionnaire.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Perform 13-UBT, Be able to understand the content of the questionnaire and answer the questions accurately, Permanent residents of Xi'an area, No previous HP eradication treatment, Agree to join the group and sign the informed consent form, Aged between 18-70. Exclusion Criteria: Complicated with serious cardiovascular, respiratory, blood, liver, kidney, nerve or endocrine system diseases, Mental disease, Gastric or esophageal surgery history, Severe atypical hyperplasia of gastric epithelium, gastric malignant tumor or other malignant diseases Pregnant or lactating women, Patients with history of penicillin allergy, Allergy to rabeprazole, bismuth dose, clindamycin, Have taken proton pump inhibitors,H2 receptor antagonists, within 2 weeks before participating in the inspection, Have taken herbs that have bacteriostatic effect or antibiotic or bismuth agents within 4 weeks before participating in the inspection.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ping Zhao, MD
Phone
13659287149
Email
peggyzhao@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shi Cheng, MD
Email
826326535@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ping Zhao, MD
Organizational Affiliation
Second Affiliated Hospital of Xi'an Jiaotong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The second affiliated hospital of Xi'an Jiaotong university
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ping Zhao, MD
Email
peggyzhao@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Influencing Factors of Helicobacter Pylori Infection and Eradication Failure

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