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

Helicobacter Pylori Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05861687
• Other study ID #: LB.02.01.XV.III.2.2.2/344/2022
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: August 1, 2021
• Est. completion date: May 20, 2022

Study information

• Verified date: May 2023
• Source: Universitas Sumatera Utara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: May 20, 2022
• Est. primary completion date: December 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Helicobacter Infections
• Helicobacter Pylori Infection
• Infections
• Recurrence

Intervention

Drug:
• Esomeprazole
Administered once a day per-oral (PO) with the dose of 0.4 mg/kg
• 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
• Amoxicillin
Administered thrice a day per-oral (PO) with the dose of 25 mg/kg
• Clarithromycin
Administered twice a day per-oral with the dose of 7.5 mg/kg

Locations

Country	Name	City	State
Indonesia	Haji Adam Malik General Hospital	Medan	North Sumatera
Indonesia	Universitas Sumatera Utara General Hospital	Medan	North Sumatera

Sponsors (1)

Lead Sponsor	Collaborator
Finni Kollins

Country where clinical trial is conducted

Indonesia, 

References & Publications (29)

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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