Bismuth-containing Quadruple Therapy for Helicobacter Pylori Eradication

  • STATUS
    Recruiting
  • End date
    Oct 9, 2023
  • participants needed
    1300
  • sponsor
    Shandong University
Updated on 9 July 2022

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.

Description

The researchers collect treatment-naive H.pylori-positive patients 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 10-day or 14-day course of bismuth-containing 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, patient compliance and cost-effectiveness index of each group were calculated.

According to the course of treatment, it is randomized into a 10-day treatment group and a 14-day treatment group. The two groups of bismuth quadruple regimens are the same, as

follows

Option 1: Amoxicillin + Clarithromycin + Bismuth + Vonoprazan fumarate Option 2: Amoxicillin + Tetracycline + Bismuth + Vonoprazan fumarate Option 3: Amoxicillin + Metronidazole + Bismuth + Vonoprazan fumarate Three options are selected according to the hospital's situation.

Details
Condition Helicobacter Pylori Infection
Treatment Amoxicillin, clarithromycin, metronidazole, Tetracycline, Bismuth Potassium Citrate, Colloidal bismuth pectin, Vonoprazan fumarate
Clinical Study IdentifierNCT05049902
SponsorShandong University
Last Modified on9 July 2022

Eligibility

Yes No Not Sure

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
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