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NCT Number: NCT05861687

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

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

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Key information

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Haji Adam Malik General Hospital, Medan, North Sumatera, Indonesia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Esomeprazole

Drug

Administered once a day per-oral (PO) with the dose of 0.4 mg/kg

Lansoprazole

Drug

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

Drug

Administered thrice a day per-oral (PO) with the dose of 25 mg/kg

Clarithromycin

Drug

Administered twice a day per-oral with the dose of 7.5 mg/kg

Primary outcomes

  1. Helicobacter pylori Stool Antigen Test

    Time frame: 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 outcomes

  1. Helicobacter pylori Stool Antigen Test

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Finni Kollins

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
May 17, 2023
Registry last updated
May 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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