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

Finni Kollins51 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Helicobacter Pylori Infection

Interventions

EsomeprazoleDRUG

Administered once a day per-oral (PO) with the dose of 0.4 mg/kg

LansoprazoleDRUG

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

AmoxicillinDRUG

Administered thrice a day per-oral (PO) with the dose of 25 mg/kg

Eligibility

Sex: ALLMin age: 2 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Universitas Sumatera Utara General Hospital

Medan, North Sumatera, Indonesia

Haji Adam Malik General Hospital

Medan, North Sumatera, Indonesia

Outcomes

Primary Outcomes

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

Time frame: 15 days

Secondary Outcomes

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

Time frame: 75 days

Data from ClinicalTrials.gov

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