A Comparison of Four Different Treatment Regimens as the First-line Treatment of Helicobacter Pylori in Chinese Children and Investigation of Resistance and Impact Factors - a Multicenter Study

What this Trial Is About

Researchers are evaluating the effectiveness of four different treatment plans for Helicobacter pylori infection in Chinese children aged 6 to 18 years. This study aims to identify which regimen is best by comparing triple therapy, sequential therapy, bismuth quadruple therapy, and concomitant therapy. The study also investigates bacterial resistance, gene factors, and changes in gut microbiota to help develop new guidelines for treating this infection in children. Participants are randomly assigned to one of four groups receiving either triple therapy, sequential therapy, bismuth quadruple therapy, or concomitant therapy over a 14-day period. Each treatment group uses specific combinations of medications, including combinations of Omeprazole, Amoxicillin, Clarithromycin, Metronidazole, and Colloidal Bismuth Subcitrate. The study measures Helicobacter pylori eradication rates 4 to 6 weeks after treatment completion. Children in the study undergo tests including a 13C-urea breath test to confirm infection clearance. Researchers also assess side effects at 2 and 4 to 6 weeks after treatment, monitor changes in gut microbiome diversity at multiple time points, and analyze genes related to drug metabolism and bacterial virulence before therapy. Patient medication compliance is checked two weeks after treatment. The trial continues until the end of 2025, with detailed monitoring of treatment impact and safety.

A Comparison of Four Different Treatment Regimens of Helicobacter Pylori in Chinese Children