Bismuth versus no bismuth for treating H. pylori-related stomach and duodenal ulcers in children

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

This project will try adding bismuth to standard antibiotic and PPI treatment to see if it helps clear H. pylori and heal ulcers in children.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 5 Years to 15 Years
• Sex: All
• Sponsor: Can Tho University of Medicine and Pharmacy (other)
• Locations: 1 site (Can Tho)
• Trial ID: NCT07260006 on ClinicalTrials.gov

What this trial studies

This interventional study compares a bismuth quadruple regimen with a standard triple therapy (PPI + amoxicillin + metronidazole) in children who have endoscopy- or histology-confirmed peptic ulcers and H. pylori infection. Participants receive one of the two assigned regimens for the standard treatment duration and return for clinic visits and tests to confirm infection clearance and ulcer healing. Parents or guardians keep a diary of symptoms, medication use, and side effects while study staff monitor safety and adherence. The study also includes a cost-effectiveness component to see whether adding bismuth yields better value alongside clinical outcomes.

Who should consider this trial

Good fit: Children with endoscopy- or histology-confirmed gastritis or peptic ulcer and confirmed H. pylori infection whose parent or legal guardian provides consent and who meet medication-use windows are ideal candidates.

Not a fit: Children who are allergic to any study medications, who have used antibiotics or bismuth recently, or who cannot complete scheduled follow-up visits are unlikely to receive benefit from participation.

Why it matters

Potential benefit: If successful, adding bismuth could increase H. pylori eradication rates and speed ulcer healing in children while remaining cost-effective.

How similar studies have performed: Bismuth-containing regimens have improved eradication rates in adults and can help overcome antibiotic resistance, but pediatric evidence is more limited and this approach is less established in children.

Eligibility criteria

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.

Where this trial is running

Can Tho

• Can Tho Children's Hospital — Can Tho, Vietnam (RECRUITING)

Study contacts

• Study coordinator: Trang Thuy Mai, MD

Conditions: Helicobacter Pylori Infection, Peptic Ulcer