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

Phase 2

Completed

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: Esomeprazole; Drug: Lansoprazole; Drug: Amoxicillin; Drug: Clarithromycin

• Registration Number: NCT05861687
• Lead Sponsor: Finni Kollins

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.

Study Timeline

• Study Start: 2021-08-01
• Primary Completion: 2021-12-07
• Study Completion: 2022-05-20
• Status Verified: 2023-05
• Study First Submitted: 2023-05-06
• Study First Submitted QC: 2023-05-16
• Last Update Submitted: 2023-05-16
• Study First Posted: 2023-05-17
• Last Update Posted: 2023-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Esomeprazole in combination with Amoxicillin and Clarithromycin	Esomeprazole	Esomeprazole : once a day per oral; 0.4 mg/kg Amoxicillin: thrice a day per oral; 25 mg/kg Clarithromycin: twice a day per-oral; 7.5 mg/kg
Esomeprazole in combination with Amoxicillin and Clarithromycin	Amoxicillin	Esomeprazole : once a day per oral; 0.4 mg/kg Amoxicillin: thrice a day per oral; 25 mg/kg Clarithromycin: twice a day per-oral; 7.5 mg/kg
Esomeprazole in combination with Amoxicillin and Clarithromycin	Clarithromycin	Esomeprazole : once a day per oral; 0.4 mg/kg Amoxicillin: thrice a day per oral; 25 mg/kg Clarithromycin: twice a day per-oral; 7.5 mg/kg
Lansoprazole in combination with Amoxicillin and Clarithromycin	Lansoprazole	Lansoprazole: once a day per oral; 15 mg if body weight \< 30 kg and 30 mg if body weight \> 30 kg Amoxicillin: thrice a day per oral; 25 mg/kg Clarithromycin: twice a day per-oral; 7.5 mg/kg
Lansoprazole in combination with Amoxicillin and Clarithromycin	Clarithromycin	Lansoprazole: once a day per oral; 15 mg if body weight \< 30 kg and 30 mg if body weight \> 30 kg Amoxicillin: thrice a day per oral; 25 mg/kg Clarithromycin: twice a day per-oral; 7.5 mg/kg
Lansoprazole in combination with Amoxicillin and Clarithromycin	Amoxicillin	Lansoprazole: once a day per oral; 15 mg if body weight \< 30 kg and 30 mg if body weight \> 30 kg Amoxicillin: thrice a day per oral; 25 mg/kg Clarithromycin: twice a day per-oral; 7.5 mg/kg

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Universitas Sumatera Utara General Hospital; 🇮🇩 Medan, North Sumatera, Indonesia

Haji Adam Malik General Hospital; 🇮🇩 Medan, North Sumatera, Indonesia