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

Can Tho University of Medicine and Pharmacy

Status: Enrolling

Conditions: Peptic Ulcer; Helicobacter Pylori Infection

Treatments: Drug: Triple therapy with PPI + Amoxicillin + Metronidazole; Drug: Bismuth quadruple therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07260006

2317/QD-DHYDCT

Details and patient eligibility

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

Enrollment: 80 estimated patients

Sex: All

Ages: 5 to 15 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Bismuth quadruple therapy

Experimental group

Description:

Patients in this arm will receive PPI, Amoxicillin, Metronidazole, and Bismuth for 14 days, with doses adjusted according to weight and age.

Treatment:

Drug: Bismuth quadruple therapy

Triple therapy with PPI + Amoxicillin + Metronidazole

Experimental group

Description:

Patients in this arm will receive PPI, Amoxicillin, Metronidazole for 14 days, with doses adjusted according to weight and age.

Treatment:

Drug: Triple therapy with PPI + Amoxicillin + Metronidazole