Study Results
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Basic Information
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COMPLETED
PHASE4
179 participants
INTERVENTIONAL
2021-06-21
2021-08-16
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Omeprazole Group
Omeprazole 20 mg BD Amoxicillin 1000 mg BD Clarithromycin 500 mg BD
Omeprazole 20 MG Capsule; Amoxicillin 1000 MG; Clarithromycin 500 MG
Orally twice daily for 2 weeks
Vonoprazan Group
Vonoprazan 20 mg BD Amoxicillin 1000 mg BD
Vonoprazan 20 MG; Amoxicillin 1000 MG
Orally twice daily for 2 weeks
Interventions
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Omeprazole 20 MG Capsule; Amoxicillin 1000 MG; Clarithromycin 500 MG
Orally twice daily for 2 weeks
Vonoprazan 20 MG; Amoxicillin 1000 MG
Orally twice daily for 2 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Histopathology by Giemsa Stain Stool Antigen
Exclusion Criteria
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Dow University of Health Sciences
OTHER
Responsible Party
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Bader Faiyaz Zuberi
Professor
Principal Investigators
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Bader F Zuberi, FCPS
Role: PRINCIPAL_INVESTIGATOR
Dow University of Health Sciences
Locations
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Dr Ruth KM Pfau Civil Hospital Karachi
Karachi, Sindh, Pakistan
Countries
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References
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Abadi ATB, Ierardi E. Vonoprazan and Helicobacter pylori Treatment: A Lesson From Japan or a Limited Geographic Phenomenon? Front Pharmacol. 2019 Apr 5;10:316. doi: 10.3389/fphar.2019.00316. eCollection 2019.
Hooi JKY, Lai WY, Ng WK, Suen MMY, Underwood FE, Tanyingoh D, Malfertheiner P, Graham DY, Wong VWS, Wu JCY, Chan FKL, Sung JJY, Kaplan GG, Ng SC. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology. 2017 Aug;153(2):420-429. doi: 10.1053/j.gastro.2017.04.022. Epub 2017 Apr 27.
Burucoa C, Axon A. Epidemiology of Helicobacter pylori infection. Helicobacter. 2017 Sep;22 Suppl 1. doi: 10.1111/hel.12403.
Crowe SE. Helicobacter pylori Infection. N Engl J Med. 2019 Mar 21;380(12):1158-1165. doi: 10.1056/NEJMcp1710945. No abstract available.
Munoz N, Sanchez-Delgado J, Baylina M, Lopez-Gongora S, Calvet X. Prevalence of Helicobacter pylori resistance after failure of first-line therapy. A systematic review. Gastroenterol Hepatol. 2018 Dec;41(10):654-662. doi: 10.1016/j.gastrohep.2018.06.014. Epub 2018 Sep 1. English, Spanish.
Ke H, Li J, Lu B, Yang C, Wang J, Wang Z, Liu L, Chen Y. The appropriate cutoff gastric pH value for Helicobacter pylori eradication with bismuth-based quadruple therapy. Helicobacter. 2021 Feb;26(1):e12768. doi: 10.1111/hel.12768. Epub 2020 Oct 21.
Wang YC, Chen YP, Ho CY, Liu TW, Chu CH, Wang HY, Liou TC. The Impact of Gastric Juice pH on the Intraluminal Therapy for Helicobacter pylori Infection. J Clin Med. 2020 Jun 14;9(6):1852. doi: 10.3390/jcm9061852.
Murakami K, Sakurai Y, Shiino M, Funao N, Nishimura A, Asaka M. Vonoprazan, a novel potassium-competitive acid blocker, as a component of first-line and second-line triple therapy for Helicobacter pylori eradication: a phase III, randomised, double-blind study. Gut. 2016 Sep;65(9):1439-46. doi: 10.1136/gutjnl-2015-311304. Epub 2016 Mar 2.
Yamada S, Kawakami T, Nakatsugawa Y, Suzuki T, Fujii H, Tomatsuri N, Nakamura H, Sato H, Okuyama Y, Kimura H, Yoshida N. Usefulness of vonoprazan, a potassium ion-competitive acid blocker, for primary eradication of Helicobacter pylori. World J Gastrointest Pharmacol Ther. 2016 Nov 6;7(4):550-555. doi: 10.4292/wjgpt.v7.i4.550.
Suzuki H, Mori H. World trends for H. pylori eradication therapy and gastric cancer prevention strategy by H. pylori test-and-treat. J Gastroenterol. 2018 Mar;53(3):354-361. doi: 10.1007/s00535-017-1407-1. Epub 2017 Nov 14.
Kato M, Ota H, Okuda M, Kikuchi S, Satoh K, Shimoyama T, Suzuki H, Handa O, Furuta T, Mabe K, Murakami K, Sugiyama T, Uemura N, Takahashi S. Guidelines for the management of Helicobacter pylori infection in Japan: 2016 Revised Edition. Helicobacter. 2019 Aug;24(4):e12597. doi: 10.1111/hel.12597. Epub 2019 May 20.
Other Identifiers
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BAD-VPZ-001
Identifier Type: -
Identifier Source: org_study_id
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