A Comparison of Four Different Treatment Regimens of Helicobacter Pylori in Chinese Children
- Conditions
- Helicobacter Infections
- Interventions
- Drug: triple therapyDrug: sequential therapyDrug: bismuth quadruple therapyDrug: concomitant therapy
- Registration Number
- NCT03365609
- Lead Sponsor
- Ying HUANG
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1440
- children 6-18 years of age who were referred for upper endoscopy and confirmed to have Hp infection
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description T-group triple therapy T-group(triple therapy) S-group sequential therapy S-group( sequential therapy) B-group bismuth quadruple therapy B-group( bismuth quadruple therapy ) C-group concomitant therapy C-group( concomitant therapy)
- Primary Outcome Measures
Name Time Method 13C-UBT 13C-UBT was assessed at 4-6 weeks after completion of therapy 13C-UBT was used to determine whether Hp treatments was successful
- Secondary Outcome Measures
Name Time Method side effects assess at 2,4-6weeks after completion of the therapy such as diarrea,rash,dark stool
changes of Shannon diversity indices for gut microbiome assess at 0,2,4-6weeks after completion of the therapy changes of the Shannon diversity indices
changes of abundances for gut microbiome assess at ,2,4-6weeks after completion of the therapy changes of abundances of the bacteria
CYP2C19 gene that impact the metabolism of PPI detect the gene before the therapy CYP2C19 gene polymorphism
virulence gene-cagA detect the gene before the therapy cagA
patient compliance assess compliance 2 weeks after the therapy good compliance is defined as taking more than 80% drugs
changes of OTU for gut microbiome assess at 0,2,4-6weeks after completion of the therapy changes of OTU
virulence gene-vacA detect the gene before the therapy vacA
Trial Locations
- Locations (1)
Children's hospital of Fudan university
🇨🇳Shanghai, Shanghai, China