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

Phase 4

Recruiting

• Conditions: Helicobacter Pylori Eradication
• Interventions: Drug: Vonoprazan and Amoxicillin; Drug: Rabeprazole, Amoxicillin, Clarithromycin and Metronidazole; Drug: Vonoprazan, Amoxicillin and Clarithromycin

• Registration Number: NCT05191888
• Lead Sponsor: Kaohsiung Medical University

Brief 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.

Study Timeline

• Study Start: 2021-08-06
• Study First Submitted: 2021-12-28
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-13
• Last Update Submitted: 2022-01-13
• Study First Posted: 2022-01-14
• Last Update Posted: 2022-01-14
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 906

Inclusion Criteria

Subjects infected with Helicobacter pylori.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
14-day vonoprazan high-dose two-in-one therapy	Vonoprazan and Amoxicillin	vonoprazan 20mg bid and amoxicillin 750mg qid
14th Rabeprazole reverse mixed therapy	Rabeprazole, Amoxicillin, Clarithromycin and Metronidazole	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
14-day vonoprazan triple therapy	Vonoprazan, Amoxicillin and Clarithromycin	vonoprazan 20mg bid and amoxicillin 1gm bid and clarithromycin 500mg bid

Primary Outcome Measures

Name	Time	Method
the rate of Helicobacter pylori	6 week after finishing study drugs	Evaluate eradication outcome by 13C uear breath test

Secondary Outcome Measures

Name	Time	Method
Adverse drug reactions	2weeks after finishing study drugs	drugs

Trial Locations

Locations (1)

Kaohsiung Medical University Hospital; 🇨🇳 Kaohsiung, Taiwan