Treatment Efficacy of Regimens With and Without Bismuth in Children With Helicobacter Pylori-Associated Peptic Ulcer Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bismuth quadruple therapy, Triple therapy with PPI + Amoxicillin + Metronidazole.
- Who it may be relevant to
- Registry conditions: Helicobacter Pylori Infection, Peptic Ulcer. Basic parameters: 5 years — 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Vietnam
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Study on the Treatment Efficacy of Regimens With and Without Bismuth in Children With Helicobacter Pylori-Associated Peptic Ulcer Disease
Overview
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
Interventions
- Drug Bismuth 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. - Drug Triple 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.
Primary outcome measures
- Eradication rate of Helicobacter pylori infection between the two treatment regimens [Time frame: Two weeks after discontinuation of acid suppression therapy following completion of the eradication regimen.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Vietnam · 1 center
- Can Tho Children's Hospital — Can Tho
Identifiers
NCT: NCT07260006 · 2317/QD-DHYDCT