Influencing Factors of Helicobacter Pylori Infection and Eradication Failure

Helicobacter Pylori Infection Clinical Trial

Official title:

Analysis of Influencing Factors of Helicobacter Pylori Infection and Eradication Failure in Outpatients of Digestive Department in Xi'an

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05226819
• Other study ID #: 2020065
• Status: Recruiting
• Phase: N/A
• Start date: February 6, 2022
• Est. completion date: March 2023

Study information

• Verified date: February 2022
• Source: Second Affiliated Hospital of Xi'an Jiaotong University
• Contact: Ping Zhao, MD
• Phone: 13659287149
• Email: peggyzhao[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 2023
• Est. primary completion date: September 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Helicobacter Infections
• Helicobacter Pylori Infection
• Infections

Intervention

Drug:
• PPI quadruple therapy
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.

Locations

Country	Name	City	State
China	The second affiliated hospital of Xi'an Jiaotong university	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	1 year
Primary	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.	1 year
Primary	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.	1 year
Primary	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.	1 year