About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Bismuth quadruple therapy
DrugA 14-day regimen including proton pump inhibitor (PPI; esomeprazole \[Nexium MUPS\]), bismuth subcitrate (or bismuth subsalicylate), amoxicillin, and metronidazole. All drug doses are adjusted according to the participant's age and weight.
Triple therapy with PPI + Amoxicillin + Metronidazole
DrugA 14-day regimen including proton pump inhibitor (PPI; esomeprazole \[Nexium MUPS\]), amoxicillin, and metronidazole. All drug doses are adjusted according to the participant's age and weight.
Treatment groups
Trial outcomes
Primary outcomes
Eradication rate of Helicobacter pylori infection between the two treatment regimens
The efficacy of the two regimens will be evaluated by comparing H. pylori eradication rates. Clinical examination and a urea breath test or stool antigen test will be performed after completion of therapy to confirm eradication. Patients will receive a 14-day treatment regimen, followed by an additional 2-4 weeks of proton pump inhibitor (PPI) therapy to promote healing of gastric or duodenal lesions.
Sponsors and contacts
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