Helicobacter Pylori Infection
Conditions
Keywords
helicobacter pylori, Vonoprazan, potassium-competitive acid inhibitor
Brief summary
RCT for comparison of Standard Triple therapy (Omeprazole+Amoxil+Clarithromycin) for H Pylori erradication with Vonoprazan+Amoxil dual therapy.
Detailed description
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.
Interventions
DRUGOmeprazole 20 MG Capsule; Amoxicillin 1000 MG; Clarithromycin 500 MG
Orally twice daily for 2 weeks
DRUGVonoprazan 20 MG; Amoxicillin 1000 MG
Orally twice daily for 2 weeks
Sponsors
Dow University of Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized Control Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Helicobacter Pylori Eradication | 4 weeks | Stool Heliobacter Pylori Antigen = Negative |
Countries
Pakistan
Outcome results
None listed