Bismuth Quadruple Therapy in Helicobacter Pylori Rescue Therapy of Different Tetracycline Doses and Frequencies.
Study Details
Study Description
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 bismuth quadruple eradication therapy. 6-8 weeks after treatment, the subjects will re-take the 13C-urea breath test. Calculate the eradication rates, adverse reaction rates and patient compliance of each group.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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 consent form, the researchers randomized the subjects in groups: subjects received a dose and frequency of tetracycline 500mg tid or qid of bismuth quadruple eradication therapy. The medication of groups are as follows. 6-8 weeks after the eradication treatment, the subjects will review the 13C-urea breath test, and the researcher records the results.
After all subjects were tested, the eradication rates, adverse reaction rates and patient compliance of each group were calculated.
According to the dose and frequency of tetracycline, it is randomized into a tid treatment group and a qid treatment group. The two groups of bismuth quadruple regimens are the same, as follows:
Tid group: Amoxicillin 1000mg bid+ Tetracycline 500mg tid+ Bismuth + Esomeprazole 40mg bid
Qid group: Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Esomeprazole 40mg bid
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Tid group Amoxicillin 1000mg bid+ Tetracycline 500mg tid+ Bismuth + Esomeprazole 40mg bid |
Drug: Tetracycline 500mg tid
Amoxicillin 1000mg bid +Tetracycline 500mg tid +Bismuth+Esomeprazole 40mg bid
Other Names:
|
| Active Comparator: Qid group Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Esomeprazole 40mg bid |
Drug: Tetracycline 500mg qid
Amoxicillin 1000mg bid +Tetracycline 500mg qid +Bismuth+Esomeprazole 40mg bid
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Eradication rate [through study completion, an average of 1.5 years]
Both intention to treat (ITT) and per-protocol (PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infections in two groups. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.
Secondary Outcome Measures
- Rate of adverse reactions [through study completion, an average of 1.5 years]
Rate of adverse reactions
- Patient compliance [through study completion, an average of 1.5 years]
Good compliance is defined as the actual dosage is within the range of 80%-100% of the dosage that should be taken.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients aged 18-70.
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Patients with H.pylori infection (Positive for rapid urease test or 13C/14C-urea breath test).
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Patients who have previous failed H. pylori eradication treatment, and ≤ 2 times.
Exclusion Criteria:
-
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%.
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Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial.
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Patients with active gastrointestinal bleeding.
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Patients with a history of upper gastrointestinal surgery.
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Patients allergic to treatment drugs.
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Patients with medication history of bismuth agents, antibiotics, proton pump inhibitor and other drugs within 4 weeks
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Gastroenterology,QiLu Hospital,Shandong University | Jinan | Shandong | China | 250012 |
Sponsors and Collaborators
- Shandong University
- Peking University Care Luzhong Hospital
- Zibo Central Hospital
- Yuncheng County Hospital of Traditional Chinese Medicine
- Taierzhuang District People's Hospital
- People's Hospital of Zhengzhou University
Investigators
- Principal Investigator: Yanqing Li, Ph.D, Qilu Hospital of Shandong University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2023000