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Clinical Trials/NCT02635191
NCT02635191UnknownPhase 4

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

Beijing Children's Hospital0 sites200 target enrollmentStarted: March 2014Last updated:
Conditions
Interventions
Drugs

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

Experimental

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

Active Comparator

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

Sponsor
Beijing Children's Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Xiwei Xu

Chief of Gastroenterology Department

Beijing Children's Hospital

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