Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06414707
Status:
COMPLETED
Last Update Posted:
2024-05-16
First Post:
2024-04-06
Brief Title:
Efficacy of Vonoprazan in Eradication of Resistant Strain of Helicobacter Pylori
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
Efficacy of Vonoprazan Versus Proton Pump Inhibitors in Combination With Antibiotics as a Triple Therapy for Eradication of Clarithromycin Resistant Strain of Helicobacter Pylori
Status:
COMPLETED
Status Verified Date:
2024-04
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 goal of this Randomized controlled trial is to assessment Efficacy of Vonoprazan versus Proton Pump Inhibitors in Combination with Antibiotics as a triple Therapy for Eradication of Clarithromycin Resistant Strain of Helicobacter Pylori H pylori
This randomized controlled study was performed on 2 groups of Egyptian patients diagnosed with dyspepsia group 1 included 160 patients received Vonoprazan 20 mg oral once daily Levofloxacin 500 mg oral once daily Amoxicillin 1 gm oral twice daily for 14 days and group 2 included 160 patients received Pantoprazole 40 mg oral twice daily Levofloxacin 500 mg oral once daily Amoxicillin 1 gm oral twice daily for 14 days All patients of the two groups were followed up for persistence of infection 8 weeks after the end of treatment by testing fecal H pylori antigen Ag
This randomized controlled study was performed on 2 groups of Egyptian patients diagnosed with dyspepsia group 1 included 160 patients received Vonoprazan 20 mg oral once daily Levofloxacin 500 mg oral once daily Amoxicillin 1 gm oral twice daily for 14 days and group 2 included 160 patients received Pantoprazole 40 mg oral twice daily Levofloxacin 500 mg oral once daily Amoxicillin 1 gm oral twice daily for 14 days All patients of the two groups were followed up for persistence of infection 8 weeks after the end of treatment by testing fecal H pylori antigen Ag
Detailed Description:
This randomized controlled trial included two groups of Egyptian patients diagnosed with dyspepsia related to Clarithromycin-resistant strains of Hpylori
Group 1 included 160 patients received Vonoprazan 20 mg oral once daily Levofloxacin 500 mg oral once daily Amoxicillin 1 gm oral twice daily for two weeks
Group 2 included 160 patients received Pantoprazole 40 mg oral twice daily Levofloxacin 500 mg oral once daily Amoxicillin 1 gm oral twice daily for 14 days
The included cases were collected from gastroenterology outpatient clinic and inpatient department at Ain shams University hospital between October 2023 and April 2024
The work had been conducted after the scientific ethics committee approval and after obtaining an informed consent from all the included cases
All cases were diagnosed with H Pylori resistant infection after clarithromycin based treatment regimen for H pylori confirmed with persistent positive test of fecal H pylori Ag before the starting of the study
All patients of the two groups were followed up for persistence of infection 8-weeks following the end of therapy by testing fecal H pylori Ag And the study end-points were compliance failure or gastrointestinal bleeding
Each participant had been exposed to comprehensive taking of history full physical assessment full laboratory examination including CBC liver profile ALT AST kidney functions test S creat fecal H pylori Ag testing before the starting of the trial and another stool sample were taken after termination of treatment by 8 weeks for evaluating of the eradication of H pylori infection and pelvi-abdominal US was done for all patients
Group 1 included 160 patients received Vonoprazan 20 mg oral once daily Levofloxacin 500 mg oral once daily Amoxicillin 1 gm oral twice daily for two weeks
Group 2 included 160 patients received Pantoprazole 40 mg oral twice daily Levofloxacin 500 mg oral once daily Amoxicillin 1 gm oral twice daily for 14 days
The included cases were collected from gastroenterology outpatient clinic and inpatient department at Ain shams University hospital between October 2023 and April 2024
The work had been conducted after the scientific ethics committee approval and after obtaining an informed consent from all the included cases
All cases were diagnosed with H Pylori resistant infection after clarithromycin based treatment regimen for H pylori confirmed with persistent positive test of fecal H pylori Ag before the starting of the study
All patients of the two groups were followed up for persistence of infection 8-weeks following the end of therapy by testing fecal H pylori Ag And the study end-points were compliance failure or gastrointestinal bleeding
Each participant had been exposed to comprehensive taking of history full physical assessment full laboratory examination including CBC liver profile ALT AST kidney functions test S creat fecal H pylori Ag testing before the starting of the trial and another stool sample were taken after termination of treatment by 8 weeks for evaluating of the eradication of H pylori infection and pelvi-abdominal US was done for all patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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