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Treatment Efficacy of Regimens With and Without Bismuth in Children With Helicobacter Pylori-Associated Peptic Ulcer Disease

RecruitingNAAges 5 Years - 15 YearsAllCan Tho University of Medicine and Pharmacy
NCT07260006 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to learn if including bismuth in the treatment helps heal stomach and duodenal ulcers caused by Helicobacter pylori (H. pylori) in children. The main questions it aims to answer are: * Does a treatment plan with bismuth work better than a plan without bismuth to clear the infection? * Is the bismuth plan more cost-effective while still safe and effective? Researchers will compare two treatment groups to see which works better. Participants will: * Take one of the two assigned treatment plans (with or without bismuth) for the standard treatment duration * Visit the clinic for checkups and tests to confirm infection clearance and monitor side effects * Keep a diary of symptoms, medication use, and any side effects

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📋 Eligibility rules (as published)
Inclusion Criteria: * Diagnosed with gastritis or peptic ulcer disease by upper gastrointestinal endoscopy or histopathology. * Meets diagnostic criteria for Helicobacter pylori infection. * Parent or legal guardian provides consent for the child to participate in the study. Exclusion Criteria: * Allergic to any of the medications in the treatment regimen. * Use of antibiotics or bismuth within the past 4 weeks, or use of antacids, H2-receptor antagonists, or proton pump inhibitors within the past 2 weeks. * Failure to return for follow-up visits after treatment.
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What it tests

  • Bismuth quadruple therapy
  • Triple therapy with PPI + Amoxicillin + Metronidazole
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Where

1 site
Can Tho Children's Hospital
Can Tho, Vietnam
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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