Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06603688
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
Study on the Efficacy and Safety of Berberine Minocycline Esomeprazole and Colloidal Bismuth Quadruple Therapy in the Initial Treatment of Helicobacter Pylori
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Study on the Efficacy and Safety of Berberine Minocycline Esomeprazole and Colloidal Bismuth Quadruple Therapy in the Initial Treatment of Helicobacter Pylori
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to evaluate the efficacy and safety of a quadruple therapy consisting of berberine hydrochloride minocycline esomeprazole and colloidal bismuth tartrate for the first phase eradication of Helicobacter pylori Assuming that the quadruple therapy of berberine hydrochloride minocycline esomeprazole and colloidal bismuth tartrate is no less effective than the bismuth containing quadruple therapy of amoxicillin and clarithromycin Patients diagnosed with Helicobacter pylori infection will be randomly assigned to one of the aforementioned treatments During the 6-week follow-up urea breath test rapid urease test or Helicobacter pylori fecal antigen test will be performed to confirm eradication
The aim of this study is to evaluate the efficacy and safety of a quadruple therapy consisting of berberine hydrochloride minocycline esomeprazole and colloidal bismuth tartrate for the first phase eradication of Helicobacter pylori Assuming that the quadruple therapy of berberine hydrochloride minocycline esomeprazole and colloidal bismuth tartrate is no less effective than the bismuth containing quadruple therapy of amoxicillin and clarithromycin Patients diagnosed with Helicobacter pylori infection will be randomly assigned to one of the aforementioned treatments During the 6-week follow-up urea breath test rapid urease test or Helicobacter pylori fecal antigen test will be performed to confirm eradication
The aim of this study is to evaluate the efficacy and safety of a quadruple therapy consisting of berberine hydrochloride minocycline esomeprazole and colloidal bismuth tartrate for the first phase eradication of Helicobacter pylori Assuming that the quadruple therapy of berberine hydrochloride minocycline esomeprazole and colloidal bismuth tartrate is no less effective than the bismuth containing quadruple therapy of amoxicillin and clarithromycin Patients diagnosed with Helicobacter pylori infection will be randomly assigned to one of the aforementioned treatments During the 6-week follow-up urea breath test rapid urease test or Helicobacter pylori fecal antigen test will be performed to confirm eradication
Detailed Description:
Screening this phase will last a maximum of 14 days and subjects eligibility will be evaluated after signing informed consent One of urea breath testrapid urease test or helicobacter pylori stool antigen test will be performed in addition to the baseline routine evaluations
Treatment Subjects are randomly assigned to treatment and will be treated for 14 days A randomization visit will take place on Day 0 and an end-of-treatment visit will take place between day 13 and 17
Follow-up includes one visits Approximately 28 days after the end of treatment Eradication of H Pylori will be confirmed by one of urea breath testrapid urease test or helicobacter pylori stool antigen test
Treatment Subjects are randomly assigned to treatment and will be treated for 14 days A randomization visit will take place on Day 0 and an end-of-treatment visit will take place between day 13 and 17
Follow-up includes one visits Approximately 28 days after the end of treatment Eradication of H Pylori will be confirmed by one of urea breath testrapid urease test or helicobacter pylori stool antigen test
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None