Actively Recruiting

Phase Not Applicable
Age: 5Years - 15Years
All Genders
NCT07260006

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

Led by Can Tho University of Medicine and Pharmacy · Updated on 2025-12-02

80

Participants Needed

1

Research Sites

86 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 5Years - 15Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Allergic to any 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

AI-Screening

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Trial Site Locations

Total: 1 location

1

Can Tho Children's Hospital

Can Tho, Vietnam, 900000

Actively Recruiting

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Research Team

T

Trang Thuy Mai, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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