RecruitingNot ApplicableNCT07260006

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

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

Sponsor

Can Tho University of Medicine and Pharmacy

Enrollment

80 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

Helicobacter Pylori Infection Peptic Ulcer

Summary

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

Min Age: 5 YearsMax Age: 15 Years

Inclusion Criteria3

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 Criteria3

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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Interventions

DRUGBismuth quadruple therapy

A 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.

DRUGTriple therapy with PPI + Amoxicillin + Metronidazole

A 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.