Overview

The Efficacy of 10-day or 14-day Course of Bismuth-containing Quadruple Therapy:A Randomized Clinical Trial

Status:
Not yet recruiting
Trial end date:
2023-12-31
Target enrollment:
0
Participant gender:
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 Tegoprazan bismuth-containing quadruple eradication therapy at 6 weeks after treatment, subjects underwent another 13C-urea breath test. Calculate the eradication rates, adverse reaction rates, patient compliance and cost-effectiveness index of each group.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Shandong University
Collaborators:
Linyi People's Hospital
Weifang Medical University
Treatments:
Bismuth
Criteria
Inclusion Criteria:

- Patients aged 18-70.

- Patients with H.pylori infection (Positive for any of the following: 13C/14C-urea
breath test, histopathology test, rapid urease test, stool H.pylori antigen test).

- Patients who have not previously received helicobacter pylori eradication therapy

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%.

- 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.