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

Kaohsiung Medical University

Status and phase: Enrolling; Phase 4

Conditions: Helicobacter Pylori Eradication

Treatments: Drug: Rabeprazole, Amoxicillin, Clarithromycin and Metronidazole; Drug: Vonoprazan, Amoxicillin and Clarithromycin; Drug: Vonoprazan and Amoxicillin

Study type: Interventional

Funder types: Other

Identifiers

NCT05191888

KMUHIRB-F(I)-20210136

Details and patient eligibility

About

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).

Full 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.

Enrollment: 906 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Subjects infected with Helicobacter pylori.

Exclusion criteria

1. Those who have ever received Helicobacter pylori sterilization treatment.
2. Those who are allergic to the drugs used in this research.
3. Those who have had stomach surgery.
4. Those with severe liver cirrhosis or uremia or malignant tumors.
5. Women who are pregnant or breastfeeding.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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906 participants in 3 patient groups

14-day vonoprazan high-dose two-in-one therapy

Active Comparator group

Description:

vonoprazan 20mg bid and amoxicillin 750mg qid

Treatment:

Drug: Vonoprazan and Amoxicillin

14-day vonoprazan triple therapy

Active Comparator group

Description:

vonoprazan 20mg bid and amoxicillin 1gm bid and clarithromycin 500mg bid

Treatment:

Drug: Vonoprazan, Amoxicillin and Clarithromycin

14th Rabeprazole reverse mixed therapy

Active Comparator group

Description:

first 7 days rabeprazole 20mg bid and amoxicillin 1gm bid and clarithromycin 500mg bid and metronidazole 500mg bid Next 7 days rabeprazole 20mg bid and amoxicillin 1gm bid

Treatment:

Drug: Rabeprazole, Amoxicillin, Clarithromycin and Metronidazole