Bismuth versus no bismuth for treating H. pylori-related stomach and duodenal ulcers in children
Official title: A Study on the Treatment Efficacy of Regimens With and Without Bismuth in Children With Helicobacter Pylori-Associated Peptic Ulcer Disease
Run by Can Tho University of Medicine and Pharmacy · NCT07260006 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 5 Years to 15 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Can Tho University of Medicine and Pharmacy Academic / other |
| Locations | 1 site (Can Tho) |
| Status | Recruiting |
| Started | October 1, 2024 |
| Main results expected | May 30, 2026 |
| Study ends | May 30, 2026 |
| Registry record updated | December 2, 2025 |
| Trial ID | NCT07260006 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Can Tho Children's Hospital
Can Tho, Vietnam Recruiting
Study contacts
- Study coordinator: Trang Thuy Mai, MD
- Email: maithuytrang2000@gmail.com
- Phone: +84 838 857 890
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This tests whether adding the probiotic Saccharomyces boulardii to bismuth-containing quadruple therapy helps adults whose H. pylori infection did not clear after prior treatments.
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Fecal transplant to help eradicate stubborn Helicobacter pylori infection
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We are testing whether a two-drug regimen of vonoprazan plus clarithromycin clears H. pylori in adults whose fecal PCR shows no clarithromycin resistance mutations.
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Bismuth-amoxicillin-vonoprazan triple therapy versus bismuth-based quadruple therapy for H. pylori infection
This will test whether a 14-day bismuth-amoxicillin-vonoprazan triple therapy works better and is as safe as a 14-day bismuth-based quadruple therapy for adults with H. pylori infection.
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P-CABs plus bismuth quadruple treatment for Helicobacter pylori infection
This study tests whether using potassium-competitive acid blockers (P-CABs) in bismuth-containing quadruple therapy works better and is safe for adults with H. pylori infection.
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Tegoprazan 50 mg twice daily plus amoxicillin versus vonoprazan 20 mg twice daily plus amoxicillin for H. pylori eradication
This trial tests whether a 14-day tegoprazan plus amoxicillin regimen works as well as a vonoprazan plus amoxicillin regimen to cure Helicobacter pylori infection in adults.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.