Helicobacter Pylori Infection, Peptic Ulcer
Conditions
Brief 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
Interventions
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.
Sponsors
Can Tho University of Medicine and Pharmacy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
5 Years to 15 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eradication rate of Helicobacter pylori infection between the two treatment regimens | Two weeks after discontinuation of acid suppression therapy following completion of the eradication regimen. | 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. |
Countries
Vietnam
Contacts
Primary ContactTrang Thuy Mai, MD
Outcome results
None listed