The Evaluation of Triple Therapy With Vonoprazan, Amoxicillin and Bismuth for Eradication of Helicobacter Pylori

Helicobacter Pylori Infection Clinical Trial

Official title:

The Evaluation of Triple Therapy With Vonoprazan, Amoxicillin and Bismuth for Eradication of Helicobacter Pylori: a Prospective, Multi-Center, Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05189444
• Other study ID #: Vonoprazan-Hp-2021
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 25, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2022
• Source: Huazhong University of Science and Technology
• Contact: Bin Cheng, Doctor
• Phone: 027-83663334
• Email: bcheng[@]tjh.tjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The eradication rate of standard quadruple therapy has become less successful due to low compliance and high resistance to antibiotics. Therefore, it is necessary to develop new treatment strategies that increase the eradication rate and reduce adverse effects. The aim of this prospective study is to investigate the efficacy of Triple Therapy with Vonoprazan, Amoxicillin, and Bismuth for eradication of Hp, compared with standard quadruple therapy.

Description:

In China, the first-line therapy to treat Helicobacter pylori (Hp) consists of a bismuth-based proton pump inhibitor (PPI) and two antibiotics for 14 days.But, eradication has become less successful due to low compliance and high resistance to antibiotics. Therefore, it is necessary to develop new treatment strategies that increase the eradication rate and reduce adverse effects. Vonoprazan is a novel potassium-competitive acid blocker more effective in suppressing acid production than proton pump inhibitors (PPIs). Several studies previously suggested that vonoprazan containing antibiotic therapy was superior to other PPI-containing therapies for Hp. Most strains of Helicobacter pylori are sensitive to amoxicillin. Bismuth salts, a topical agent, which are available in our country, have a synergistic effect on antibiotics and decrease the bacterial load. Therefore, the investigators performed a prospective, multi-center, randomized trial, to investigate the efficacy of Triple Therapy with Vonoprazan, Amoxicillin, and Bismuth for eradication of Hp, compared with standard quadruple therapy.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 672
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Helicobacter pylori infected patients comfirmed by 13C/14C UBT

• age 18~65

Exclusion Criteria:

• prior Hp eradication therapy including amoxicillin and clarithromycin

• previous gastric resection

• allergic to the drugs used in this study

• previous use of proton pump inhibitors, bismuth, H2 receptor antagonist or antibiotics, probiotics within 4 weeks of the study

• Patients who were pregnant or lactating

• Patients taking NSAIDs, alcoholic or with other serious disease (e.g. hepatopathy, heart disease, nephropathy#diabete mellitus, hypertension…) effect the evaluation of this study

• Can't express the complaint correctly

Related Conditions & MeSH terms

• Helicobacter Pylori Infection

Intervention

Drug:
• Vonoprazan
20mg bid
• Amoxicillin
0.75g tid
• Esomeprazole
20mg bid
• Amoxicillin
1.0g bid
• Clarithromycin
0.5g bid
• Bismuth potassium citrate
0.22g bid

Locations

Country	Name	City	State
China	Tongji Hospital, Tongji Medical College, HUST	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

References & Publications (5)

Ang TL, Ang D. Helicobacter pylori Treatment Strategies in Singapore. Gut Liver. 2021 Jan 15;15(1):13-18. doi: 10.5009/gnl19308. Review. — View Citation

Gunaratne AW, Hamblin H, Clancy A, Magat AJMC, Dawson MVM, Tu J, Borody TJ. Combinations of antibiotics and vonoprazan for the treatment of Helicobacter pylori infections-Exploratory study. Helicobacter. 2021 Oct;26(5):e12830. doi: 10.1111/hel.12830. Epub — View Citation

Kao CY, Sheu BS, Wu JJ. Helicobacter pylori infection: An overview of bacterial virulence factors and pathogenesis. Biomed J. 2016 Feb;39(1):14-23. doi: 10.1016/j.bj.2015.06.002. Epub 2016 Apr 1. Review. — View Citation

Kiyotoki S, Nishikawa J, Sakaida I. Efficacy of Vonoprazan for Helicobacter pylori Eradication. Intern Med. 2020 Jan 15;59(2):153-161. doi: 10.2169/internalmedicine.2521-18. Epub 2019 Jun 27. Review. — View Citation

Rokkas T, Gisbert JP, Malfertheiner P, Niv Y, Gasbarrini A, Leja M, Megraud F, O'Morain C, Graham DY. Comparative Effectiveness of Multiple Different First-Line Treatment Regimens for Helicobacter pylori Infection: A Network Meta-analysis. Gastroenterolog — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Helicobacter pylori eradication	to investigate the efficacy of Triple Therapy with Vonoprazan, Amoxicillin and Bismuth for eradication of Hp, compared with standard quadruple therapy.	6 weeks after treatment initiation
Secondary	Incidence of adverse events	to investigate the incidence of adverse events of Triple Therapy with Vonoprazan, Amoxicillin and Bismuth, compared with standard quadruple therapy.	2 weeks and 6 weeks after treatment initiation