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

Finni Kollins

Status and phase: Completed; Phase 3; Phase 2

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Amoxicillin; Drug: Lansoprazole; Drug: Esomeprazole; Drug: Clarithromycin

Study type: Interventional

Funder types: Other

Identifiers

NCT05861687

LB.02.01.XV.III.2.2.2/344/2022

Details and patient eligibility

About

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

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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51 participants in 2 patient groups

Esomeprazole in combination with Amoxicillin and Clarithromycin

Experimental group

Description:

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

Treatment:

Drug: Clarithromycin

Drug: Esomeprazole

Drug: Amoxicillin

Lansoprazole in combination with Amoxicillin and Clarithromycin

Active Comparator group

Description:

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

Treatment:

Drug: Clarithromycin

Drug: Lansoprazole

Drug: Amoxicillin