Status:
UNKNOWN
Bismuth Quadruple Therapy for Helicobacter Pylori Rescue Therapy of Different Tetracycline Doses and Frequencies.
Lead Sponsor:
Shandong University
Collaborating Sponsors:
Peking University Care Luzhong Hospital
Zibo Central Hospital
Conditions:
Helicobacter Pylori Infection
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
The researchers collect H.pylori-positive patients who need rescue therapy from the outpatient clinic. The subjects were randomized to receive a dose and frequency of tetracycline 500mg tid or qid of ...
Detailed Description
The researchers collect H.pylori-positive patients who need rescue therapy from the outpatient clinic. If the subject meets the selection criteria but not the exclusion criteria, and signs an informed...
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 previous failed H. pylori eradication treatment, and ≤ 2 times.
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 :
June 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2023
Estimated Enrollment :
407 Patients enrolled
Trial Details
Trial ID
NCT05432115
Start Date
June 25 2022
End Date
October 1 2023
Last Update
January 31 2023
Active Locations (1)
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1
Qilu Hospital
Jinan, Shandong, China, 250012