Efficacy of Vonoprazan in Eradication of Resistant Strain of Helicobacter Pylori

Helicobacter Pylori Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06414707
• Other study ID #: FMASU R288/2023
• Status: Completed
• Phase: Phase 3
• Start date: October 12, 2023
• Est. completion date: April 4, 2024

Study information

• Verified date: April 2024
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

This randomized controlled trial included two groups of Egyptian patients diagnosed with dyspepsia related to Clarithromycin-resistant strains of H.pylori.

• 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 U/S was done for all patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: April 4, 2024
• Est. primary completion date: April 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• patients with dyspepsia related to Clarithromycin-resistant strains of H.pylori. 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.

• Must be able to swallow tablets.

Exclusion Criteria:

• Cases with drug allergy from drugs included in the study.

• those having inflammatory-bowel diseases.

• those with malabsorption syndrome.

• those having gastroenterology malignancy.

• patients on immunotherapy.

• HIV patients.

Related Conditions & MeSH terms

• Helicobacter Pylori Infection

Intervention

Drug:
• Vonoprazan, Amoxicillin and Levofloxacin
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.
• Pantoprazole 40mg, Amoxicillin and Levofloxacin
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.

Locations

Country	Name	City	State
Egypt	Mostafa Elfors	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment the fecal H.Pylori Ag after receiving Vonoprazan in combination with antibiotics as a triple therapy in patients with Clarithromycin-resistant strain of H.Pylori infection.	comparison between the efficiency of Vonoprazan and Pantoprazole in eradication of Clarithromycin-resistant strain of H.Pylori.	All patients of the two groups were followed up for 2 months.