MedTrace Logo

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

NCT03365609 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1440

Last updated 2025-02-28

No results posted yet for this 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.

Conditions

  • Helicobacter Infections

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

Sponsors & Collaborators

  • Guangzhou Women and Children's Medical Center

    collaborator OTHER

  • The Children's Hospital of Zhejiang University School of Medicine

    collaborator OTHER

  • Beijing Children's Hospital

    collaborator OTHER

  • Tang-Du Hospital

    collaborator OTHER

  • Ying HUANG

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-20
Primary Completion
2025-10-01
Completion
2025-12-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03365609 on ClinicalTrials.gov