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This study aims to compare the recurrence rates of Esomeprazole and Lansoprazole in triple combination therapy to eradicate H.pylori infection in children. The participants were divided into two groups, those who received Esomeprazole and those who received Lansoprazole
H. pylori eradication therapy is still contentious. A treatment that is uncomplicated, well-tolerated, and boasts an efficiency rate of more than 80% is recommended.
PPIs are a type of acid-sensitive drug which is most beneficial in preventing the degradation of drugs in the stomach. In developing countries, Esomeprazole and Lansoprazole were mainly selected as a drug of choice. Major influential factors such as Esomeprazole's additional antioxidant ability, are comparable to vitamin C. This is due to its ability to scavenge Diphenyl Picrylhydrazyl (DPPH) free radicals at low concentrations. Lansoprazole also possess similar ability, albeit needs a slightly higher concentration to reach a similar effect. In terms of IC50 values, both drugs have a substantial advantage over vitamin C, earning them the title of 'potentially ideal' agents in the treatment algorithm. Furthermore, numerous studies mention that children better tolerate PPIs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Esomeprazole in combination with Amoxicillin and Clarithromycin | Experimental | Esomeprazole : once a day per oral; 0.4 mg/kg Amoxicillin: thrice a day per oral; 25 mg/kg Clarithromycin: twice a day per-oral; 7.5 mg/kg |
|
| Lansoprazole in combination with Amoxicillin and Clarithromycin | Active Comparator | Lansoprazole: once a day per oral; 15 mg if body weight < 30 kg and 30 mg if body weight > 30 kg Amoxicillin: thrice a day per oral; 25 mg/kg Clarithromycin: twice a day per-oral; 7.5 mg/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esomeprazole | Drug | Administered once a day per-oral (PO) with the dose of 0.4 mg/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Helicobacter pylori Stool Antigen Test | The stool of the subjects will be assessed on day-15 after drug administration. A negative result indicates that patient is infection-free | 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Helicobacter pylori Stool Antigen Test | The stool of the subjects will be analyzed on day-90 after drug administration to assess whether a reinfection is present. A negative result indicates that patient is infection-free | 75 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitas Sumatera Utara General Hospital | Medan | North Sumatera | 20124 | Indonesia | ||
| Haji Adam Malik General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
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| Lansoprazole | Drug | Administered once a day per-oral (PO) with the dose of 15 mg if individual's body mass was <30 kg, and 30 mg if it was >30 kg |
|
| Amoxicillin | Drug | Administered thrice a day per-oral (PO) with the dose of 25 mg/kg |
|
| Clarithromycin | Drug | Administered twice a day per-oral with the dose of 7.5 mg/kg |
|
| Medan |
| North Sumatera |
| 20136 |
| Indonesia |
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| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| D064747 | Lansoprazole |
| D000658 | Amoxicillin |
| D017291 | Clarithromycin |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
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