Clinical trial NCT04901117: Bismuth-containing Quadruple Therapy for Helicobacter Pylori Eradication: A Randomized Clinical Trial of 10 and 14 Days
Official title: Bismuth-containing Quadruple Therapy for Helicobacter Pylori Eradication: A Multicenter Randomized Clinical Trial of 10 and 14 Days
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori
Bismuth-containing quadruple regimen
Lead sponsor: Shandong University
Sponsor class: OTHER
Collaborators: name: The Affiliated Hospital of Qingdao University
name: The People's Hospital of Guangrao
name: Weihai Municipal Hospital
name: Shandong Province Third hospital
name: Taian City Central Hospital
name: Jining No.2 People's Hospital
name: Maternity and Child Care Health Center of Dezhou
name: Zoucheng People's Hospital
name: Heze Municipal 3rd people's hospital
name: Yuncheng Chengxin Hospital
name: Peking University Care Luzhong Hospital
name: Qihe County City Hospital
name: Weifang People's Hospital
name: Qilu Hospital of Shandong University
name: Shandong Electric Power Central Hospital
First posted: 2021-05-25
Enrollment: 1300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This trial is a multi-center, open-label, non-inferiority, randomized controlled trial.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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 whose birth place and residence within five years of birth are Shandong Province.
* 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 current residence is not in Shandong Province.
* 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.

Primary outcomes:
measure: Eradication rate
timeFrame: Immediately after follow-up check.
Secondary outcomes:
measure: Rate of adverse reactions
timeFrame: Immediately after follow-up check.
measure: Patient compliance
timeFrame: Immediately after follow-up check.
measure: Cost-effectiveness index
timeFrame: Immediately after follow-up check.
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu hosipital
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Xiuli Zuo, MD,PhD
role: PRINCIPAL_INVESTIGATOR
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