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NCT Number: NCT07260006

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

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

Recruiting

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Key information

Conditions

Helicobacter Pylori Infection Digestive System Diseases Duodenal Diseases Gastrointestinal Diseases Intestinal Diseases Peptic Ulcer Stomach Diseases

Age range

5 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Can Tho Children's Hospital

Can Tho, 900000, Vietnam

Location status: Recruiting

Location contact

Loan Thi Thuy Le, MD, PhD

CONTACT

[email protected]

+84 914 375 231

Trang Thuy Mai, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

bismuth quadruple therapy

Drug

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

Drug

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.

Primary outcomes

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Trang Thuy Mai, MD

CONTACT

[email protected]

+84 838 857 890

Sponsors and collaborators

Lead sponsor

Can Tho University of Medicine and Pharmacy

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 2, 2025
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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