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

Can Tho University of Medicine and Pharmacy80 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Helicobacter Pylori Infection Peptic Ulcer

Interventions

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 + MetronidazoleDRUG

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.

Eligibility

Sex: ALLMin age: 5 YearsMax age: 15 Years

Medical Language ↔ Plain English

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.

Locations (1)

Can Tho Children's Hospital

Can Tho, Vietnam

RECRUITING

Outcomes

Primary Outcomes

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.

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

Central Contacts

Trang Thuy Mai, MD

CONTACT

+84 838 857 890 maithuytrang2000@gmail.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.