Influencing Factors of Helicobacter Pylori Infection and Eradication Failure

NCT05226819 | Unknown

• 1 other identifier: 2020065
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori; Infection; Risk Factor; Questionnaire

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (3)

H. pylori negative group

NO INTERVENTION

No Intervention

H. pylori positive and successful eradication group

OTHER

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.

Drug: PPI quadruple therapy

H. pylori positive and eradication failure group

OTHER

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.

Drug: PPI quadruple therapy

Interventions

PPI quadruple therapy 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 and successful eradication group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Xi'an Jiaotong University: lead

Study Sites (1)

The second affiliated hospital of Xi'an Jiaotong university

Xi'an, Shaanxi, 710004, China

RECRUITING

MeSH Terms

Conditions

Infections

Study Officials

• Ping Zhao, MD

  Second Affiliated Hospital of Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ping Zhao, MD

CONTACT

13659287149; peggyzhao@163.com

Shi Cheng, MD

CONTACT

826326535@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2022
• First Posted: February 7, 2022
• Study Start: February 6, 2022
• Primary Completion: September 1, 2022
• Study Completion: March 1, 2023
• Last Updated: February 8, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)