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

NCT07260006 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-12-02

No results posted yet for this 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

Conditions

  • Helicobacter Pylori Infection
  • Peptic Ulcer

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.

Sponsors & Collaborators

  • Can Tho University of Medicine and Pharmacy

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2026-05-30
Completion
2026-05-30

Countries

  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07260006 on ClinicalTrials.gov