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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 15
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Viet Nam
Can Tho Children's Hospital
RECRUITING
Can Tho
Contact Information
Primary
Trang Thuy Mai, MD
maithuytrang2000@gmail.com
+84 838 857 890
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2026-05-30
Participants
Target number of participants: 80
Treatments
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.
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.
Sponsors
Leads: Can Tho University of Medicine and Pharmacy

This content was sourced from clinicaltrials.gov