Status:
COMPLETED
Bismuth-containing Quadruple Therapy for Helicobacter Pylori First-line Treatment of Different Tetracycline Doses
Lead Sponsor:
Shandong University
Collaborating Sponsors:
Peking University Care Luzhong Hospital
Yuncheng Traditional Chinese Medicine Hospital
Conditions:
Helicobacter Pylori Infection
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
The researchers collect treatment-naive H.pylori-positive patients from the outpatient clinic. The subjects were randomized to receive a dose and frequency of tetracycline 500mg tid or qid of bismuth ...
Detailed Description
The researchers collect treatment-naive H.pylori-positive patients from the outpatient clinic. If the subject meets the selection criteria but not the exclusion criteria, and signs an informed consent...
Eligibility Criteria
Inclusion
- Patients aged 18-70.
- Patients with H.pylori infection (Positive for rapid urease test or 13C/14C-urea breath test).
- Patients who have never received H. pylori eradication treatment.
Exclusion
- Patients with serious underlying diseases, such as liver insufficiency (Aspartate aminotransferase or alanine aminotransferase greater than 1.5 times the normal value), renal insufficiency (Cr≥2.0mg/dL or glomerular filtration rate \<50 ml/min), immunosuppression, malignant tumors, Coronary heart disease or coronary artery stenosis ≥75%.
- Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial.
- Patients with active gastrointestinal bleeding.
- Patients with a history of upper gastrointestinal surgery.
- Patients allergic to treatment drugs.
- Patients with medication history of bismuth agents, antibiotics, proton pump inhibitor and other drugs within 4 weeks
- Patients with other behaviors that may increase the risk of illness, such as alcohol and drug abuse
- Patients who are unwilling or incapable to provide informed consents.
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2024
Estimated Enrollment :
406 Patients enrolled
Trial Details
Trial ID
NCT05431075
Start Date
July 1 2022
End Date
February 1 2024
Last Update
March 27 2024
Active Locations (6)
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1
Zhengzhou Central Hospital
Zhengzhou, Henan, China
2
Qilu hosipital
Jinan, Shandong, China, 257000
3
Taierzhuang District People's Hospital
Taierzhuang, Shandong, China
4
Yuncheng Hospital of Traditional Chinese Medicine
Yuncheng, Shandong, China