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

Helicobacter Infections Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

Eligible children were randomly divided into four groups: standard triple therapy, sequential therapy, bismuth quadruple therapy and concomitant therapy. The course of treatment is 14 days. The primary outcome measure was the Hp eradication rate at 4-6 weeks after completion of treatment which was confirmed by a negative of 13 UBT. Secondary outcome measures included side effects, impact factor and changes of microbiome after the therapy. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03365609
Study type Interventional
Source Children's Hospital of Fudan University
Contact Ying Zhou, master
Phone 13917394900
Email nnyyhhs@163.com
Status Recruiting
Phase N/A
Start date September 20, 2017
Completion date December 31, 2025
View Details
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