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

Study Overview
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Brief Summary
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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.

Detailed Description
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Eligible children were randomly divided into four groups: standard triple therapy, sequential therapy, bismuth quadruple therapy and concomitant therapy. The course of treatment is 14 days. The primary outcome measure was the Hp eradication rate at 4-6 weeks after completion of treatment which was confirmed by a negative of 13 UBT. Secondary outcome measures included side effects, impact factor and changes of microbiome after the therapy.

Official Title
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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

Conditions
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Helicobacter Infections

Intervention / Treatment
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* Drug: triple therapy
* Drug: sequential therapy
* Drug: bismuth quadruple therapy
* Drug: concomitant therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children 6-18 years of age who were referred for upper endoscopy and confirmed to have Hp infection Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 6 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: T-group<br>T-group(triple therapy) | Drug: triple therapy<br>* Omeprazole+Amoxicillin+Clarithromycin<br>|
| Experimental: S-group<br>S-group( sequential therapy) | Drug: sequential therapy<br>* the first 7 days : Omeprazole+Amoxicillin, the last 7 days: Omeprazole+Clarithromycin+Metronidazole<br>|
| Experimental: B-group<br>B-group( bismuth quadruple therapy ) | Drug: bismuth quadruple therapy<br>* Omeprazole+Amoxicillin+Metronidazole+Colloidal Bismuth Subcitrate<br>|
| Experimental: C-group<br>C-group( concomitant therapy) | Drug: concomitant therapy<br>* Omeprazole+Amoxicillin+Clarithromycin+Metronidazole<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 13C-UBT | 13C-UBT was used to determine whether Hp treatments was successful | 13C-UBT was assessed at 4-6 weeks after completion of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| side effects | such as diarrea,rash,dark stool | assess at 2,4-6weeks after completion of the therapy | 
| changes of Shannon diversity indices for gut microbiome | changes of the Shannon diversity indices | assess at 0,2,4-6weeks after completion of the therapy | 
| changes of OTU for gut microbiome | changes of OTU | assess at 0,2,4-6weeks after completion of the therapy | 
| changes of abundances for gut microbiome | changes of abundances of the bacteria | assess at ,2,4-6weeks after completion of the therapy | 
| CYP2C19 gene that impact the metabolism of PPI | CYP2C19 gene polymorphism | detect the gene before the therapy | 
| virulence gene-cagA | cagA | detect the gene before the therapy | 
| virulence gene-vacA | vacA | detect the gene before the therapy | 
| patient compliance | good compliance is defined as taking more than 80% drugs | assess compliance 2 weeks after the therapy |