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The study aims to test the efficacy of 7 days vs. 14 days of Vonoprazan-triple therapy in the eradication of Helicobacter Pylori infection in adolescents and young children.
After being informed about the study details, all eligible participants (or their legal guardians) will give informed written consent to be involved. After a one week screening, eligible participants will be randomized to Vonoprazan plus Amoxicillin plus Clarithromycin triple therapy for either 14 days (group 1), or 7 days (group 2) at a 1:1 ratio. After the end of therapy, H. Pylori eradication will be evaluated after 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 14-days Vonoprazan-based triple therapy | Active Comparator | 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 . |
|
| 7-days 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 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vonoprazan | Drug | Participants will receive Vonoprazan 20 mg tablets twice daily before meals. |
|
| Measure | Description | Time Frame |
|---|---|---|
| H. Pylori eradication rate | Number of participants who will achieve a negative H. pylori antigen detection test after the end of therapy. | 4 weeks after completion of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events during treatment. | Type and frequency of treatment-related adverse effects in both arms | From first dose of treatment until 7 or 14 days of treatment regimen assigned. |
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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 University. | Alexandria | Egypt |
Clinico-laboratory data can be shared, but participant-specific identity data cannot be shared to maintain participant confidentiality.
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| ID | Term |
|---|---|
| D005756 | Gastritis |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D013272 | Stomach Diseases |
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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 |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 |
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1:1 assignment.
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| Amoxicillin | Drug | Participants will receive Amoxicillin 50 mg/kg/day capsules or suspension [maximum daily dose: 2 g]. |
|
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| Clarithromycin | Drug | Participants will receive Clarithromycin 20 mg/kg/day tablets or suspension [maximum daily dose: 1 g]. |
|
|
| 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 |