Clinical trial NCT06250634: Esomeprazole/Vonoprazan Combined With High-dose Amoxicillin Dual Therapy for Primary Eradication of Helicobacter Pylori Infection
Official title: Esomeprazole / Vonoprazan Combined With High-dose Amoxicillin Dual Therapy for Primary Eradication of Helicobacter Pylori Infection: a Multi-center, Prospective, Open-label, Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Helicobacter Pylori Infection
Lead sponsor: The Third Xiangya Hospital of Central South University
Sponsor class: OTHER
Collaborators: name: The Second People's Hospital of Huaihua
name: Yueyang Hospital of Traditional Chinese Medicine
First posted: 2024-02-09
Enrollment: 806
Sex: ALL
Minimum age (years): 14
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study intends to collect the clinical data of patients with Helicobacter pylori infection, and to observe and count the high-dose double therapy and the traditional quadruple / triple therapy ( i.e., esomeprazole + amoxicillin double high-dose double therapy and esomeprazole + amoxicillin + clarithromycin + colloidal bismuth tartrate traditional quadruple therapy or Vonoprazan + amoxicillin double high-dose double therapy and Vonoprazan + amoxicillin + clarithromycin triple therapy ). The eradication rate of Helicobacter pylori was compared between the two different regimens respectively, and the efficacy, safety and compliance of different regimens were compared. It provides a new reference for clinical treatment of Helicobacter pylori, and has great clinical value and significance for simplifying the anti-Helicobacter-pylori treatment plan, increasing patient compliance, and exploring efficient anti-Helicobacter-pylori therapy suitable for the Chinese population.


Eligibility criteria: Inclusion Criteria:

1. patients aged 14-90 years, no requirement for gender;
2. patients diagnosed as H. pylori infection by at least one of the following tests: carbon-13/14 urea breath test (13C/14C-UBT) or immuno-histochemical staining of biopsy specimens;
3. patients with no use of antibiotics, bismuth or Chinese traditional medicines with antibacterial effects in the previous 4 weeks of 13C/14C-UBT, and no H2 receptor antagonists, PPIs, P-CAB or other drugs affecting H .pylori activity within the previous 2 weeks of 13C/14C-UBT;
4. patients without history of receiving H. pylori eradication therapy.

Exclusion Criteria:

1. patients with serious diseases or clinical conditions that may interfere with the evaluation of the results of the study, such as severe heart, liver, lung, and renal insufficiency, low immunity, and so on;
2. patients with allergy to penicillin or any research-program-related drugs;
3. patients with mental illness and communication disorders;
4. patients in pregnancy or lactation;
5. patients with severe gastrointestinal diseases, such as gastrointestinal tumors, gastrointestinal bleeding, other organic diseases, etc.;
6. patients who were participating in other clinical trials;
7. patients who were considered inappropriate for enrollment after evaluation by the researchers.

Primary outcomes:
measure: Helicobacter pylori eradication rate
timeFrame: pre-intervention and at least 30 days post-intervention
Secondary outcomes:
measure: Adverse events
timeFrame: the 3rd, 7th, and 14th day during the intervention
measure: Compliance
timeFrame: the 14th day during the intervention
Other outcomes:
Locations:
city: Changsha
country: China
facility: outpatient department of gastroenterology of the Third Xiangya Hospital of Central South University
state: Hunan
Study officials:
References: