Clinical trial NCT05861687: Recurrence Rate Comparison Between Esomeprazole and Lansoprazole in Eradicating Helicobacter Pylori Infection Among Children
Official title: Comparative Recurrence Rate Investigation of Esomeprazole Versus Lansoprazole in Triple-Combination Therapy to Eradicate Helicobacter Pylori Infection Among Pediatrics: Multicentre, Randomized, and Controlled Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori
Triple therapy
Children
Esomeprazole
Lansoprazole
Lead sponsor: Universitas Sumatera Utara
Sponsor class: OTHER
First posted: 2023-05-17
Enrollment: 51
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Helicobacter pylori Stool Antigen Test
timeFrame: 15 days
Secondary outcomes:
measure: Helicobacter pylori Stool Antigen Test
timeFrame: 75 days
Other outcomes:
Locations:
city: Medan
country: Indonesia
facility: Universitas Sumatera Utara General Hospital
state: North Sumatera
city: Medan
country: Indonesia
facility: Haji Adam Malik General Hospital
state: North Sumatera
Study officials:
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