NCT05191888

14-day PCAB-based High-dose Dual Therapy and14-day PCAB-based Triple Therapy vs 14-day PPI-based Reverse Hybrid Therapy

14-day PCAB-based and Reverse Hybrid Therapy Fro Helicobacter Pylori

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 906 (estimated)
• Sponsor: Kaohsiung Medical University · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

1. Test for Helicobacter pylori. The test items include urease test, histology, bacterial culture, serology, and urea breath test. At least two positive results can be used to confirm the diagnosis. 2. To ensure that the research results are not artificially distorted, this trial is a randomized study. Random allocation (which means that the subjects will use the "random number table generated by a computer similar to the lottery" to determine the treatment group) accept one of the following schemes (1:1:1).

Detailed description

Helicobacter pylori (H.pylori) infect more than 50% of humans globally. This study were (1) to test whether the efficacies of 14-day PCAB-based high-dose dual therapy and 14-day PPI-based reverse hybrid therapy can achieve a higher eradication rate than 14-day PCAB-based triple therapy in the first-line treatment of H pylori infection, (2) to compare the eradication rates of 14-day PCAB-based and PPI-based bismuth quadruple therapies in the second-line treatment of H pylori infection, and (3) to examine the impacts of antibiotic resistance of H pylori as well as CYP3A4, CYP2C19 and IL-1B -511 genotypes of host on the eradication efficacies of anti-H pylori treatments.

Conditions

• Helicobacter Pylori Eradication

Interventions

Type	Name	Description
DRUG	Vonoprazan and Amoxicillin	14-day vonoprazan high-dose two-in-one therapy
DRUG	Vonoprazan, Amoxicillin and Clarithromycin	14-day vonoprazan triple therapy
DRUG	Rabeprazole, Amoxicillin, Clarithromycin and Metronidazole	14th Rabeprazole reverse mixed therapy

Timeline

• Start date: 2021-08-06
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2022-01-14
• Last updated: 2022-01-14

Locations

1 site across 1 country: Taiwan