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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

906 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-06

Study Completion Date

2024-12-31

Brief Summary

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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).

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Detailed Description

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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

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Helicobacter Pylori Eradication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1. 14-day vonoprazan high-dose two-in-one therapy
2. 14-day vonoprazan triple therapy
3. 14th Rabeprazole reverse mixed therapy

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

vonoprazan 20mg bid and amoxicillin 750mg qid

Group Type ACTIVE_COMPARATOR

Vonoprazan and Amoxicillin

Intervention Type DRUG

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

14-day vonoprazan triple therapy

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

Group Type ACTIVE_COMPARATOR

Vonoprazan, Amoxicillin and Clarithromycin

Intervention Type DRUG

14-day vonoprazan triple therapy

14th Rabeprazole reverse mixed therapy

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

Group Type ACTIVE_COMPARATOR

Rabeprazole, Amoxicillin, Clarithromycin and Metronidazole

Intervention Type DRUG

14th Rabeprazole reverse mixed therapy

Interventions

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Vonoprazan and Amoxicillin

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

Intervention Type DRUG

Vonoprazan, Amoxicillin and Clarithromycin

14-day vonoprazan triple therapy

Intervention Type DRUG

Rabeprazole, Amoxicillin, Clarithromycin and Metronidazole

14th Rabeprazole reverse mixed therapy

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No