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

Helicobacter Pylori Eradication Clinical Trial

Official title:

14-day PCAB-based and Reverse Hybrid Therapy Fro Helicobacter Pylori

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05191888
• Other study ID #: KMUHIRB-F(I)-20210136
• Status: Recruiting
• Phase: Phase 4
• Start date: August 6, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2022
• Source: Kaohsiung Medical University
• Contact: Deng-Chyang Wu, MD, PhD
• Phone: 886-7-*3121101
• Email: dechwu[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 906
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Helicobacter Pylori Eradication

Intervention

Drug:
• Vonoprazan and Amoxicillin
14-day vonoprazan high-dose two-in-one therapy
• Vonoprazan, Amoxicillin and Clarithromycin
14-day vonoprazan triple therapy
• Rabeprazole, Amoxicillin, Clarithromycin and Metronidazole
14th Rabeprazole reverse mixed therapy

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the rate of Helicobacter pylori	Evaluate eradication outcome by 13C uear breath test	6 week after finishing study drugs
Secondary	Adverse drug reactions	drugs	2weeks after finishing study drugs