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RecruitingNCT07260006Updated Dec 2, 2025

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

An interventional study of Bismuth quadruple therapy and Triple therapy with PPI + Amoxicillin + Metronidazole in Helicobacter Pylori Infection and Peptic Ulcer, sponsored by Can Tho University of Medicine and Pharmacy. Recruiting at 1 site in Vietnam. Open to participants aged 5 Years to 15 Years. Per ClinicalTrials.gov, last updated 2025-12-02.

Sponsored by Can Tho University of Medicine and Pharmacy · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2026, 4 months ago, but the record still lists the study as recruiting.
  • Registered 1 year 1 month after the study started (first participant enrolled Oct 2024, registered Nov 2025).
  • Started Oct 2024; still recruiting 2 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
5 Years to 15 Years
Sex
All
01

Study 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
02

Conditions studied

  • Helicobacter Pylori Infection
  • Peptic Ulcer

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03

In context

Peptic Ulcer

193 studies on the registry are indexed under Peptic Ulcer; 31 are open to participants now.

This study's planned enrollment of 80 is below the median of 150 across 142 interventional studies indexed under Peptic Ulcer.

Browse Peptic Ulcer studies →

Lead sponsor

Can Tho University of Medicine and Pharmacy is the lead sponsor of 33 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 15 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    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.

    Drug: Bismuth quadruple therapy

  • Experimental
    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.

    Drug: Triple therapy with PPI + Amoxicillin + Metronidazole

Interventions

  • DrugBismuth 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.

  • 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.

06

What researchers measure

Primary outcomes

  1. Eradication rate of Helicobacter pylori infection between the two treatment regimens

    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.

    Time frame: Two weeks after discontinuation of acid suppression therapy following completion of the eradication regimen.

07

Study locations

1 of 1 sites recruiting
  • Can Tho Children's Hospital
    Can Tho, 900000, Vietnam
    • Loan Thi Thuy Le, MD, PhD · Contact · lttloan@ctump.edu.vn · +84 914 375 231
    • Trang Thuy Mai, MD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07260006
Lead sponsor
Can Tho University of Medicine and Pharmacy
Responsible party
Mai Thùy Trang (Doctor, Can Tho University of Medicine and Pharmacy) — Principal investigator
First posted
Dec 2, 2025
Start date
Oct 1, 2024
Primary completion
May 30, 2026 (estimated)
Completion
May 30, 2026 (estimated)
Last update
Dec 2, 2025

Study contacts

Trang Thuy Mai, MD
Contact
maithuytrang2000@gmail.com
+84 838 857 890

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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