Influencing Factors of Helicobacter Pylori Infection and Eradication Failure

NCT ID: NCT05226819

Last Updated: 2022-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-06

Study Completion Date

2023-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Helicobacter Pylori Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

H. pylori negative group

No Intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

H. pylori positive and successful eradication group

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.

Group Type OTHER

PPI quadruple therapy

Intervention Type DRUG

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.

H. pylori positive and eradication failure group

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.

Group Type OTHER

PPI quadruple therapy

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Second Affiliated Hospital of Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ping Zhao, MD

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital of Xi'an Jiaotong University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The second affiliated hospital of Xi'an Jiaotong university

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ping Zhao, MD

Role: CONTACT

13659287149

Shi Cheng, MD

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ping Zhao, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020065

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.