Overview
Bismuth-containing Quadruple Therapy for Helicobacter Pylori Eradication
Status:
Recruiting
Recruiting
Trial end date:
2023-10-01
2023-10-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The researchers collect treatment-naive H.pylori-positive patients from the outpatient clinic. The subjects were randomized to receive a 10-day or 14-day course of 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, patient compliance and cost-effectiveness index of each group.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Shandong UniversityCollaborators:
Heze Municipal 3rd people's hospital
Maternity and Child Care Health Center of Dezhou
PKUcare luzhong hospital
The First Affiliated Hospital with Nanjing Medical UniversityTreatments:
Amoxicillin
Bismuth
Clarithromycin
Metronidazole
Potassium Citrate
Tetracycline
Criteria
Inclusion Criteria:- Patients aged 18-65.
- Patients with H.pylori infection (Positive for any of the following: H.pylori culture,
histopathology test, rapid urease test, 13C/14C-urea breath test, stool H.pylori
antigen test).
- Patients who have never received H. pylori eradication treatment.
Exclusion Criteria:
- Patients with serious underlying diseases, such as liver insufficiency (Aspartate
aminotransferase or alanine aminotransferase greater than 3 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 whose re-check 13C/14C-urea breath test is negative before the start of the
test.
- Patients who are unwilling or incapable to provide informed consents.