Ignite Creation Date:
2024-05-06 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 2:22 PM
Study NCT ID:
NCT05189444
Status:
UNKNOWN
Last Update Posted:
2022-03-22
First Post:
2021-12-29
Brief Title:
The Evaluation of Triple Therapy With Vonoprazan Amoxicillin and Bismuth for Eradication of Helicobacter Pylori
Sponsor:
Huazhong University of Science and Technology
Organization:
Huazhong University of Science and Technology
Study Overview
Official Title:
The Evaluation of Triple Therapy With Vonoprazan Amoxicillin and Bismuth for Eradication of Helicobacter Pylori a Prospective Multi-Center Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2022-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 daysBut 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None