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Tailored Therapy for Helicobacter Pylori in Children

NCT02635191 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2015-12-18

No results posted yet for this study

Summary

This study is designed to compare the eradication rates，safety and compliance of tailored therapy to those of standard triple therapy in children with H. pylori infection. The primary purpose is to compare the eradication rates of children with H. pylori infection treated with tailored therapy to those treated with standard triple therapy. The secondary purpose is to evaluate the safety, compliance and factors that might affect eradication rates.

Conditions

  • Helicobacter Pylori Infection

Interventions

DRUG

Tailored Group

All the patients who enrolled in this arm will be received endoscopy followed by biopsy for antimicrobial susceptibility testing and cytochrome P450 isoenzyme 2C19 genotype. 10 days tailored therapy will be given including one Proton Pump Inhibitor ( Rabeprazole0.4-0.5mg/kg.d,bid. or Esomeprazole0.8-1.0mg/kg.d,bid) and two antibiotics (Amoxicillin30-50mg/kg.d bid, Clarithromycin15-20mg/kg.d bid, Metronidazole15-20mg/kg.d bid ) based on the cytochrome P450 isoenzyme 2C19 genotype and the antimicrobial susceptibility.

DRUG

Standard group

All the patients who enrolled in this arm will be treated by Omeprazole(0.8-1.0mg/kg.d,bid), Amoxicillin (30-50mg/kg.d bid)and Clarithromycin (15-20mg/kg.d bid) .

Sponsors & Collaborators

  • Beijing Children's Hospital

    lead OTHER

Principal Investigators

  • Xiwei Xu, MD · Beijing Children's Hosipital of Capital Medical University,China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2016-03-31
Completion
2016-07-31

Countries

  • China

Study Locations

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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 NCT02635191 on ClinicalTrials.gov