Helicobacter Pylori Infection
Conditions
Brief summary
The study aimed to compare the efficacy and safety of 7-day and 14-day vonoprazan-amoxicillin-tetracycline triple therapy with 14-day vonoprazan-amoxicillin-tetracycline-bismuth quadruple therapy for the eradication of Helicobacter pylori. Subjects were randomized to receive the intervention and were reviewed by 13C-urea breath test after 6 weeks. The eradication rates, adverse reaction rates and patient adherence were calculated.
Detailed description
H. pylori-positive patients without eradication history were recruited according to inclusion and exclusion criteria and randomized to the intervention: 14-day quadruple regimen: Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid + Bismuth 220mg bid for 14 days 14-day triple regimen: Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid 14 days 7-day triple regimen: Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid 7 days Subjects were asked to record adverse events and 6 weeks after treatment, 13C-urea breath test was tested for confirmation. The eradication rates, adverse reaction rates and patient adherence were calculated and analysed, and the results were analysed to provide more information for eradication regimens of H. pylori.
Interventions
DRUGVonoprazan-Amoxicillin-Tetracycline-Bismuth quadruple regimen for 14 days
Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid + Bismuth 220mg bid for 14 days
DRUGVonoprazan-Amoxicillin-Tetracycline triple regimen for 14 days
Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid for 14 days
DRUGVonoprazan-Amoxicillin-Tetracycline triple regimen for 7 days
Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid for 7 days
Sponsors
Binzhou Maternal and Child Health Hospital
Zibo Maternal and Child Health Hospital
Zaozhuang Municipal Hospital
Linyi Yizhou Hospital
Feicheng Municipal People's Hospital
Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Patients aged 18-70 years old; 2. Patients with H.pylori infection (positive rapid urease test, 13C/14C-urea breath test); 3. Patients without previous treatment for H. pylori eradication.
Exclusion criteria
1. Patients with serious underlying diseases, such as liver insufficiency (Aspartate aminotransferase or alanine aminotransferase greater than 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%; 2. Patients with active gastrointestinal bleeding; 3. Patients with a history of upper gastrointestinal surgery; 4. Patients allergic to treatment drugs; 5. Patients with medication history of bismuth, antibiotics within 4 weeks, or proton pump inhibitor within 2 weeks; 6. Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial; 7. Patients with other behaviors that may increase the risk of illness, such as alcohol and drug abuse; 8. Patients who are unwilling or incapable to provide informed consents.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eradication rate | Immediately after follow-up check | 13C-urea breath test was used to determine whether eradication was successful. 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 the three 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
| Measure | Time frame | Description |
|---|---|---|
| Rate of adverse reactions | Immediately after follow-up check | A questionnaire on drug-related adverse reactions needs to be completed after treatment. |
| Patient compliance | Immediately after follow-up check | A questionnaire on the number of missed and overdosed doses of medication needs to be completed after treatment. Good compliance was defined as taking 80%-120% of the pills. |
Countries
China
Outcome results
None listed