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

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).

Study Overview

• Status: Recruiting
• Conditions: Helicobacter Pylori Eradication
• Intervention / Treatment: Drug: Vonoprazan and Amoxicillin; Drug: Vonoprazan, Amoxicillin and Clarithromycin; Drug: Rabeprazole, Amoxicillin, Clarithromycin and Metronidazole

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 Type: Interventional
• Enrollment (Anticipated): 906
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Deng-Chyang Wu, MD, PhD; Phone Number: 7451 886-7-*3121101; Email: dechwu@yahoo.com

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 807
    • Recruiting
    • Kaohsiung Medical University Hospital
    • Contact: Deng-Chyang Wu, MD,PHD; Phone Number: 7451 886-7-3121101; Email: dechwu@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 14-day vonoprazan high-dose two-in-one therapy; vonoprazan 20mg bid and amoxicillin 750mg qid	Drug: Vonoprazan and Amoxicillin; 14-day vonoprazan high-dose two-in-one therapy
ACTIVE_COMPARATOR: 14-day vonoprazan triple therapy; vonoprazan 20mg bid and amoxicillin 1gm bid and clarithromycin 500mg bid	Drug: Vonoprazan, Amoxicillin and Clarithromycin; 14-day vonoprazan triple therapy
ACTIVE_COMPARATOR: 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	Drug: Rabeprazole, Amoxicillin, Clarithromycin and Metronidazole; 14th Rabeprazole reverse mixed therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the rate of Helicobacter pylori	Evaluate eradication outcome by 13C uear breath test	6 week after finishing study drugs

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse drug reactions	drugs	2weeks after finishing study drugs

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 6, 2021
• Primary Completion (ANTICIPATED): December 31, 2024
• Study Completion (ANTICIPATED): December 31, 2024

Study Registration Dates

• First Submitted: December 28, 2021
• First Submitted That Met QC Criteria: January 13, 2022
• First Posted (ACTUAL): January 14, 2022

Study Record Updates

• Last Update Posted (ACTUAL): January 14, 2022
• Last Update Submitted That Met QC Criteria: January 13, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Metronidazole; Rabeprazole; Amoxicillin; Clarithromycin
• Other Study ID Numbers: KMUHIRB-F(I)-20210136

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No