Helicobacter Pylori Infection
Conditions
Keywords
Helicobacter pylori, Triple therapy, Children, Esomeprazole, Lansoprazole
Brief 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.
Interventions
DRUGEsomeprazole
Administered once a day per-oral (PO) with the dose of 0.4 mg/kg
DRUGLansoprazole
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
DRUGAmoxicillin
Administered thrice a day per-oral (PO) with the dose of 25 mg/kg
DRUGClarithromycin
Administered twice a day per-oral with the dose of 7.5 mg/kg
Sponsors
Finni Kollins
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Helicobacter pylori Stool Antigen Test | 15 days | The stool of the subjects will be assessed on day-15 after drug administration. A negative result indicates that patient is infection-free |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Helicobacter pylori Stool Antigen Test | 75 days | 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 |
Countries
Indonesia
Outcome results
None listed