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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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05191888
Enrollment
906
Registered
2022-01-14
Start date
2021-08-06
Completion date
2024-12-31
Last updated
2022-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter Pylori Eradication

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.

Interventions

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

14-day vonoprazan triple therapy

DRUGRabeprazole, Amoxicillin, Clarithromycin and Metronidazole

14th Rabeprazole reverse mixed therapy

Sponsors

Kaohsiung Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
the rate of Helicobacter pylori6 week after finishing study drugsEvaluate eradication outcome by 13C uear breath test

Secondary

MeasureTime frameDescription
Adverse drug reactions2weeks after finishing study drugsdrugs

Countries

Taiwan

Contacts

Primary ContactDeng-Chyang Wu, MD, PhD
dechwu@yahoo.com886-7-*3121101

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026