NCT05861687

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Finni Kollins · Academic / Other
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DRUG	Esomeprazole	Administered once a day per-oral (PO) with the dose of 0.4 mg/kg
DRUG	Lansoprazole	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
DRUG	Amoxicillin	Administered thrice a day per-oral (PO) with the dose of 25 mg/kg
DRUG	Clarithromycin	Administered twice a day per-oral with the dose of 7.5 mg/kg

Timeline

• Start date: 2021-08-01
• Primary completion: 2021-12-07
• Completion: 2022-05-20
• First posted: 2023-05-17
• Last updated: 2023-05-17

Locations

2 sites across 1 country: Indonesia