Treatment Efficacy of Regimens With and Without Bismuth in Children With Helicobacter Pylori-Associated Peptic Ulcer Disease
NCT ID: NCT07260006
Last Updated: 2025-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2024-10-01
2026-05-30
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Bismuth quadruple therapy
Patients in this arm will receive PPI, Amoxicillin, Metronidazole, and Bismuth for 14 days, with doses adjusted according to weight and age.
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.
Triple therapy with PPI + Amoxicillin + Metronidazole
Patients in this arm will receive PPI, Amoxicillin, Metronidazole for 14 days, with doses adjusted according to weight and age.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Meets diagnostic criteria for Helicobacter pylori infection.
* Parent or legal guardian provides consent for the child to participate in the study.
Exclusion Criteria
* 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.
5 Years
15 Years
ALL
No
Sponsors
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Can Tho University of Medicine and Pharmacy
OTHER
Responsible Party
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Mai Thùy Trang
Doctor
Locations
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Can Tho Children's Hospital
Can Tho, , Vietnam
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2317/QD-DHYDCT
Identifier Type: -
Identifier Source: org_study_id
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