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

A Study on the 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

Study Overview

• Status: Recruiting
• Conditions: Peptic Ulcer; Helicobacter Pylori Infection
• Intervention / Treatment: Drug: Bismuth quadruple therapy; Drug: Triple therapy with PPI + Amoxicillin + Metronidazole

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Trang Thuy Mai, MD; Phone Number: +84 838 857 890; Email: maithuytrang2000@gmail.com

Study Locations

• Vietnam
  • Can Tho, Vietnam, 900000
    • Recruiting
    • Can Tho Children's Hospital
    • Contact: Loan Thi Thuy Le, MD, PhD; Phone Number: +84 914 375 231; Email: lttloan@ctump.edu.vn
    • Principal Investigator: Trang Thuy Mai, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Two weeks after discontinuation of acid suppression therapy following completion of the eradication regimen.

Collaborators and Investigators

• Sponsor: Can Tho University of Medicine and Pharmacy

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: November 21, 2025
• First Submitted That Met QC Criteria: November 21, 2025
• First Posted (Actual): December 2, 2025

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 21, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Duodenal Diseases; Peptic Ulcer; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Azoles; Imidazoles; Amides; Penicillin G; beta-Lactams; Lactams; Nitroimidazoles; Nitro Compounds; Ampicillin; Penicillins; Metronidazole; Amoxicillin
• Other Study ID Numbers: 2317/QD-DHYDCT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No