Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT03365609
NA

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

Sponsor: Ying HUANG

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

6 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

1440

Start Date

2017-09-20

Completion Date

2025-12-31

Last Updated

2025-02-28

Healthy Volunteers

No

Interventions

DRUG

triple therapy

Omeprazole+Amoxicillin+Clarithromycin

DRUG

sequential therapy

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

DRUG

bismuth quadruple therapy

Omeprazole+Amoxicillin+Metronidazole+Colloidal Bismuth Subcitrate

DRUG

concomitant therapy

Omeprazole+Amoxicillin+Clarithromycin+Metronidazole

Locations (1)

Children's hospital of Fudan university

Shanghai, Shanghai Municipality, China