Tailored Therapy Versus Standard Triple Therapy for Helicobacter Pylori Eradication in Children: A Randomized Trial
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 200
- Primary Endpoint
- Compare the eradication rates in each group
Study Overview
Brief 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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 4 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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;
Arms & Interventions
Tailored Group
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.
Intervention: Tailored Group (Drug)
Standard group
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.
Intervention: Standard group (Drug)
Outcomes
Primary Outcomes
Compare the eradication rates in each group
Time Frame: One month after treatment
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Xiwei Xu
Chief of Gastroenterology Department
Beijing Children's Hospital