Vonoprazan in Helicobacter Pylori Treatment an RCT

Study Overview
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Brief Summary
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RCT for comparison of Standard Triple therapy (Omeprazole+Amoxil+Clarithromycin) for H Pylori erradication with Vonoprazan+Amoxil dual therapy.

Detailed Description
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OBJECTIVE To compare the efficacy of Vonoprazan based dual treatment versus PPI based treatment for the eradication of Helicobacter pylori infection. OPERATIONAL DEFINITION Helicobacter Pylori infection: Hp infection will be labelled by any one of following investigation: Helicobacter Pylori Stool Antigen Histopathology on Giemsa Stain MATERIAL AND METHODS: Study Design: Randomized control trial. Setting: This study will be conducted in the Medical OPD and Medical Unit 1 of Dr. Ruth K.M. Pfau, Civil Hospital Karachi affiliated with Dow University of Health Sciences DATA COLLECTION PROCEDURE: All patients presenting to the OPD or Medical Unit 1 of Dr. Ruth KM Pfau, Civil Hospital Karachi and fulfilling the inclusion criteria will be included after taking informed consent. The participants will be randomly allocated to 2 groups with help of random number table and will be treated for 2 weeks. Group A: will be given: Capsule Amoxicillin 1 gm twice daily Tablet Clarithromycin 500 mg twice a day Capsule Omeprazole 20 mg twice a day Group B will be given: Capsule Amoxicillin 1 gm twice daily Tablet Vonoprazan 20 mg twice a day Confirmation of Hp eradication will be done by stool Hp antigen test 4 weeks after completion of treatment. DATA ANALYSIS Data will be stratified according to age & gender. Frequency of gender & mean (SD) of age will be compared between groups using Pearson's Chi-square test and Student's t-test respectively. Frequency of Hp eradication between two groups will be compared using Pearson's chi-square test. A p value < .05 will be taken as significant.

Official Title
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Comparison of Vonoprazan and Amoxicillin Dual Therapy With Standard Triple Therapy With Proton Pump Inhibitor for Helicobacter Pylori Eradication; a Randomized Control Trial

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: Omeprazole 20 MG Capsule; Amoxicillin 1000 MG; Clarithromycin 500 MG
* Drug: Vonoprazan 20 MG; Amoxicillin 1000 MG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Helicobacter Pylori Positive by any one of following: Histopathology by Giemsa Stain Stool Antigen Exclusion Criteria: • Previous surgery of the stomach such as partial gastrectomy. Allergy to any of the antibiotics used in the study. Intake of antibiotics, PPIs, corticosteroids, or nonsteroidal anti-inflammatory drugs within the last 2 weeks. Pregnant or lactating females. Alcohol abuse or drug addiction. Severe neurological or psychiatric disorder.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Control Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Omeprazole Group<br>Omeprazole 20 mg BD Amoxicillin 1000 mg BD Clarithromycin 500 mg BD | Drug: Omeprazole 20 MG Capsule; Amoxicillin 1000 MG; Clarithromycin 500 MG<br>* Orally twice daily for 2 weeks<br>* Other names: Omeprazole Group;|
| Experimental: Vonoprazan Group<br>Vonoprazan 20 mg BD Amoxicillin 1000 mg BD | Drug: Vonoprazan 20 MG; Amoxicillin 1000 MG<br>* Orally twice daily for 2 weeks<br>* Other names: Vonoprazan Group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Helicobacter Pylori Eradication | Stool Heliobacter Pylori Antigen = Negative | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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helicobacter pylori, Vonoprazan, potassium-competitive acid inhibitor