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RCT for comparison of Standard Triple therapy (Omeprazole+Amoxil+Clarithromycin) for H Pylori erradication with Vonoprazan+Amoxil dual therapy.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omeprazole Group | Active Comparator | Omeprazole 20 mg BD Amoxicillin 1000 mg BD Clarithromycin 500 mg BD |
|
| Vonoprazan Group | Experimental | Vonoprazan 20 mg BD Amoxicillin 1000 mg BD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omeprazole 20 MG Capsule; Amoxicillin 1000 MG; Clarithromycin 500 MG | Drug | Orally twice daily for 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Helicobacter Pylori Eradication | Stool Heliobacter Pylori Antigen = Negative | 4 weeks |
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Inclusion Criteria:
Histopathology by Giemsa Stain Stool Antigen
Exclusion Criteria:
• Previous surgery of the stomach such as partial gastrectomy.
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| Name | Affiliation | Role |
|---|---|---|
| Bader F Zuberi, FCPS | Dow University of Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Ruth KM Pfau Civil Hospital Karachi | Karachi | Sindh | 74400 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31024299 | Result | 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. | |
| 28456631 | Result | 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. |
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| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D002214 | Capsules |
| D017291 | Clarithromycin |
| D000658 | Amoxicillin |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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Randomized Control Trial
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| Vonoprazan 20 MG; Amoxicillin 1000 MG | Drug | Orally twice daily for 2 weeks |
|
|
| 28891138 | Result | Burucoa C, Axon A. Epidemiology of Helicobacter pylori infection. Helicobacter. 2017 Sep;22 Suppl 1. doi: 10.1111/hel.12403. |
| 30893536 | Result | Crowe SE. Helicobacter pylori Infection. N Engl J Med. 2019 Mar 21;380(12):1158-1165. doi: 10.1056/NEJMcp1710945. No abstract available. |
| 30180998 | Result | 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. |
| 33089598 | Result | 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. |
| 32545856 | Result | 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. |
| 26935876 | Result | 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. |
| 27867688 | Result | 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. |
| 29138921 | Result | 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. |
| 31111585 | Result | 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. |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |