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The trial tends to evaluate the efficacy of vonoprazan-based triple therapy in eradicating H. Pylori infection in adolescent patients in Egypt, in comparison to standard treatment regimens to determine if it offers superior eradication rates (VONTAPE trial).
The VONTAPE trial will compare two treatment regimens for Helicobacter pylori eradication among adolescent patients presented to the gastroenterology department in an Egyptian institute. the eligible subjects will be randomly assigned to one of the two protocols (vonoprazan based vs. proton pump inhibitor-based triple therapy) for two weeks. then the eradication rates will be compared between the two study groups to see if there is a difference in efficacy.
The currently available eradication regimens in our country show a low to intermediate eradication rate (50-75%). At the same time, H. pylori infection is prevalent.
Recently, the FDA approved vonoprazan-based regimens for adult H. pylori infection with high eradication rates even in the settings of clarithromycin antibiotic resistance.
In the VOTSAPE trial, we will test this efficacy in the < 18 years adolescents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vonoprazan-based triple therapy | Experimental | Vonoprazan tablets 20 mg twice daily plus Amoxicillin 50 mg/kg/day capsules or suspension [maximum daily dose 2 g] plus Clarithromycin 20 mg/kg/day tablets or suspension [maximum daily dose 1 g] The triple combination will be given for 14 days |
|
| Proton pump-based triple therapy "standard triple therapy" | Active Comparator | Esomeprazole tablets [20 mg/day if < 30 kg and 40 mg/daily if ≥ 30 kg] on two divided daily doses plus Amoxicillin 50 mg/kg/day capsules or suspension [maximum daily dose 2 g] plus Clarithromycin 20 mg/kg/day tablets or suspension [maximum daily dose 1 g] The triple combination will be given for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vonoprazan | Drug | an acid suppressor therapy that inhibits the H+, K+-ATPase enzyme system in a potassium-competitive manner. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Helicobacter Pylori eradication rate | Number of patients who will test negative for H. pylori after treatment completion. | 4 weeks after completion of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| The adverse events during therapy | Treatment-related adverse effects (TRAEs) such as abdominal discomfort, diarrhea, vomiting, nausea, flatulence, taste disturbance, or loss of appetite, the need for discontinuation of the H. pylori therapy; and/or headache. | During the treatment duration, and the end of the 2 weeks treatment protocol |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sameh A Lashen, MD | Alexandria University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine | Alexandria | 21521 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41131746 | Derived | Lashen SA, Shamseyea MM, Metwally RH, Abou-Farrag G, Elkaragy ES. Vonoprazan-Based Triple Therapy Versus Esomeprazole-Based Triple Therapy for H. pylori Eradication in Adolescents (VONTAPE): A Randomized, Double-Blind Controlled Trial. Helicobacter. 2025 Sep-Oct;30(5):e70083. doi: 10.1111/hel.70083. |
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| ID | Term |
|---|---|
| C552956 | 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine |
| D000658 | Amoxicillin |
| D017291 | Clarithromycin |
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 |
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| Amoxicillin | Drug | An antibiotic of penicillins antibiotic group |
|
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| Clarithromycin | Drug | An antibiotic of macrolide group |
|
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| Esomeprazole | Drug | An acid suppressor therapy that blocks the proton pump. |
|
|
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001562 | Benzimidazoles |