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

NCT07260006 | Recruiting

• 1 other identifier: 2317/QD-DHYDCT
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

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.

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

Study Arms (2)

Bismuth quadruple therapy

EXPERIMENTAL

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

Triple therapy with PPI + Amoxicillin + Metronidazole

EXPERIMENTAL

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

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.

Bismuth quadruple therapy

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.

Triple therapy with PPI + Amoxicillin + Metronidazole

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Can Tho University of Medicine and Pharmacy: lead

Study Sites (1)

Can Tho Children's Hospital

Can Tho, 900000, Vietnam

RECRUITING

MeSH Terms

Conditions

Peptic Ulcer

Interventions

Amoxicillin; Metronidazole

Condition Hierarchy (Ancestors)

Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Trang Thuy Mai, MD

CONTACT

+84 838 857 890; maithuytrang2000@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 2, 2025
• Study Start: October 1, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-07

Locations

VN (1)