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Clinical efficacy evaluation of individualized eradication of Helicobacter pylori based on antibiotic resistance gene detection for initial and remedial treatment

Clinical efficacy evaluation of individualized eradication of Helicobacter pylori based on antibiotic resistance gene detection for initial and remedial treatment

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095247
Enrollment
Unknown
Registered
2025-01-03
Start date
2022-09-01
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter pylori infection

Interventions

EBAC group:Esomeprazole 20mg bid + bismuth potassium citrate 220mg bid + amoxicillin 1g bid + clarithromycin 0.5g bid for 14 days
EBAX group:Esomeprazole 20mg bid + bismuth potassium citrate 220mg bid + amoxicillin 1g bid + clarithromycin 0.5g bid/levofloxacin 500mg qd/tetracycline 500mg tid for 14 days
EBAL group:Esomeprazole 20mg bid + bismuth potassium citrate 220mg bid + amoxicillin 1g bid + levofloxacin 500mg qd for 14 days
R-EBAX group:Esomeprazole 20mg bid + bismuth potassium citrate 220mg bid + amoxicillin 1g bid + clarithromycin 0.5g bid/levofloxacin 500mg qd/tetracycline 500mg tid for 14 days

Sponsors

The Affiliated Hospital of Qingdao University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Age 18-65 years, male or female; (2) The presence of Hp infection as evidenced by a positive C13 or C14 breath test, rapid urease test, or histopathology; (3) No penicillin or amoxicillin allergy; (4) No history of allergy to other drugs in the study protocol; (5) Consent to gastroscopy and biopsy for histopathology; (6) Signed consent to participate in the study voluntarily, actively cooperate with the follow-up, and bear the related medical expenses.

Exclusion criteria

Exclusion criteria: (1) Presence of active gastrointestinal bleeding; (2) History of previous upper gastrointestinal surgery; (3) Pregnant and lactating women and those who are unwilling to use contraception during the trial period; (4) Patients with other concurrent serious diseases that affect the evaluation of this study, such as severe liver disease, lung disease, heart disease, kidney disease, malignant tumors, and alcoholism disorders; (5) Patients who are unable to express their complaints correctly, such as psychosis, severe neurosis, and are unable to cooperate with this test; (6) History of allergy to the test drug; (7) Those who are unable or unwilling to provide informed consent; (8) The presence of other factors that, in the opinion of the investigator, may affect the accuracy of the test results and the interests of the patients.

Design outcomes

Primary

MeasureTime frame
Hp eradication success rate;

Secondary

MeasureTime frame
Patient compliance;The incidence of adverse reactions;Safety;

Countries

China

Contacts

Public ContactZibin Tian

The Affiliated Hospital of Qingdao University

tianzbsun@163.com+86 186 6180 5123

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026