RecruitingNot ApplicableNCT03365609

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

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


Sponsor

Ying HUANG

Enrollment

1,440 participants

Start Date

Sep 20, 2017

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 6 YearsMax Age: 18 Years

Inclusion Criteria1

  • children 6-18 years of age who were referred for upper endoscopy and confirmed to have Hp infection

Exclusion Criteria1

  • patients were excluded if they had taken proton pump inhibitors, H2-receptor antagonists or antibiotics in the 4 weeks prior to the study. Patients with known antibiotic allergy,hepatic impairment or kidney failure were also excluded. Patients who received Hp therapy before were also excluded.

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Interventions

DRUGtriple therapy

Omeprazole+Amoxicillin+Clarithromycin

DRUGsequential therapy

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

DRUGbismuth quadruple therapy

Omeprazole+Amoxicillin+Metronidazole+Colloidal Bismuth Subcitrate

DRUGconcomitant therapy

Omeprazole+Amoxicillin+Clarithromycin+Metronidazole


Locations(1)

Children's hospital of Fudan university

Shanghai, Shanghai Municipality, China

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NCT03365609