Recurrence Rate Comparison Between Esomeprazole and Lansoprazole in Eradicating Helicobacter Pylori Infection Among Children

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Comparative Recurrence Rate Investigation of Esomeprazole Versus Lansoprazole in Triple-Combination Therapy to Eradicate Helicobacter Pylori Infection Among Pediatrics: Multicentre, Randomized, and Controlled Trials

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: Esomeprazole
* Drug: Lansoprazole
* Drug: Amoxicillin
* Drug: Clarithromycin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has positive clinical symptoms (gastrointestinal pain, nausea, vomiting, hematemesis, or melena) Subject had been diagnosed with H.pylori infection prior to endoscopy and rapid urease testing Exclusion Criteria: subject has a history of using antibiotics or non-steroidal anti-inflammatory medicines (NSAIDs) within 14 days prior to surgery subject has a concomitant systemic disease (e.g., renal failure, liver cirrhosis, cancer, etc.) that could theoretically affect the subject's response to treatment Incomplete triple pharmacologic treatment due to the subject's lack of medication adherence

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Esomeprazole in combination with Amoxicillin and Clarithromycin<br>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 | Drug: Esomeprazole<br>* Administered once a day per-oral (PO) with the dose of 0.4 mg/kg<br>Drug: Amoxicillin<br>* Administered thrice a day per-oral (PO) with the dose of 25 mg/kg<br>Drug: Clarithromycin<br>* Administered twice a day per-oral with the dose of 7.5 mg/kg<br>|
| Active Comparator: Lansoprazole in combination with Amoxicillin and Clarithromycin<br>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 | Drug: Lansoprazole<br>* 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<br>Drug: Amoxicillin<br>* Administered thrice a day per-oral (PO) with the dose of 25 mg/kg<br>Drug: Clarithromycin<br>* Administered twice a day per-oral with the dose of 7.5 mg/kg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helicobacter pylori, Triple therapy, Children, Esomeprazole, Lansoprazole