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

Condition(s) studied

Investigational drug(s) / intervention(s)

triple therapy: Omeprazole+Amoxicillin+Clarithromycin

sequential therapy: the first 7 days : Omeprazole+Amoxicillin, the last 7 days: Omeprazole+Clarithromycin+Metronidazole

bismuth quadruple therapy: Omeprazole+Amoxicillin+Metronidazole+Colloidal Bismuth Subcitrate

concomitant therapy: Omeprazole+Amoxicillin+Clarithromycin+Metronidazole

Study summary

With the resistance of Helicobacter pylori increasing, low and unsatisfactory eradication rate (64%) have been observed with standard triple therapy in European children. Which regimen is appropriate for Chinese children? There is no large scale, multi center studies in China about treatment, CYP2C19 gene polymorphism, resistance rate and resistance genotype. Investigators want to perform a research to compare four different treatment regimens（triple therapy, sequential therapy, bismuth quadruple therapy and concomitant therapy）as the first-line treatment of Helicobacter pylori in Chinese children and investigation of resistance, impact factors and changes of microbiota after the therapy. The results of the study will provide theoretical basis to make the new guideline of diagnosis and therapy of Helicobacter pylori in Chinese children. It advance instruct and norm the clinical practice for Chinese pediatrician to increase the cure rate of Helicobacter pylori and decrease the resistance.

Eligibility

Primary outcome measure(s)

• 13C-UBT — 13C-UBT was assessed at 4-6 weeks after completion of therapy
  13C-UBT was used to determine whether Hp treatments was successful

Trial sites (1)