Tailored Therapy for Helicobacter Pylori in Children

Study Overview
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Brief Summary
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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.

Detailed Description
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Between March 2014 and March 2016, 200 children with upper gastrointestinal symptoms (4-18 years) and H. pylori infection will be recruited at Beijing Children Hospital.After the informed consents are obtained from the guardians, the children will be randomly classified into the two group: 10 days standard triple therapy (Omeprazole 0.8-1.0mg/kg.d,bid, Amoxicillin 30-50mg/kg.d bid， Clarithromycin 15-20mg/kg.d bid), or 10 days tailored therapy including one Proton Pump Inhibitor ( Rabeprazole 0.4-0.5mg/kg.d,bid. or Esomeprazole 0.8-1.0mg/kg.d,bid) and two antibiotics (Amoxicillin 30-50mg/kg.d bid, Clarithromycin 15-20mg/kg.d bid, Metronidazole15-20mg/kg.d bid) based on antibiotics susceptibility and cytochrome P450 isoenzyme 2C19 genotype. Eradication status will be reassessed in four weeks after treatment.

Official Title
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Tailored Therapy Versus Standard Triple Therapy for Helicobacter Pylori Eradication in Children: A Randomized Trial

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: Tailored Group
* Drug: Standard group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of H. pylori infection. Presence of upper gastrointestinal symptoms. Referred for upper endoscopy at Beijing Children's Hospital Exclusion Criteria: Presence of endoscopy contraindications The administration of any drug that could influence the study results including proton pump inhibitors, H2-receptor blockers, bismuth salts and antibiotics within the previous four weeks; Gastrointestinal malignancy; Previous gastric or esophageal surgery; Severe concomitant diseases History of allergy to any of the study drugs;

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tailored Group<br>In tailored therapy, medications will be adjusted according to the antimicrobial susceptibility testing (including Clarithromycin sensitivity) and cytochrome P450 isoenzyme 2C19 genotype. 10 days regimen will be prescribed. | Drug: Tailored Group<br>* 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.<br>* Other names: AmoxicillinTongdamoxing®;|
| Active Comparator: Standard group<br>In standard triple therapy, children 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) for 10 days. | Drug: Standard group<br>* 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) .<br>* Other names: ClarithromycinKlacid®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the eradication rates in each group | The efficacy of H. pylori eradication between the standard triple therapy and tailored therapy based on the results of antimicrobial resistance(including Clarithromycin sensitivity) by using H. pylori culture and cytochrome P450 isoenzyme 2C19 genotype. Eradication status will be reassessed in one month after treatment. | One month after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helicobacter pylori, Therapy, Children