Influencing Factors of Helicobacter Pylori Infection and Eradication Failure

Xi'an Jiaotong University

Status: Unknown

Conditions: Helicobacter Pylori Infection

Treatments: Drug: PPI quadruple therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05226819

2020065

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 3 patient groups

H. pylori negative group

No Intervention group

Description:

No Intervention

H. pylori positive and successful eradication group

Other group

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.

Treatment:

Drug: PPI quadruple therapy

H. pylori positive and eradication failure group

Other group

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.

Treatment:

Drug: PPI quadruple therapy