Tailored Therapy for Helicobacter Pylori in Children

December 16, 2015 updated by: Xiwei Xu, Beijing Children's Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Recruiting

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Tailored Group
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.
Other Names:
  • "Rabeprazole"" Pariet®"
  • "Esomeprazole"" Nexium®"
  • "Metronidazole""Yabao®"
  • "Amoxicillin""Tongdamoxing®"
Active Comparator: 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.
Drug: Standard group
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) .
Other Names:
  • "Amoxicillin""Tongdamoxing®"
  • "Omeprazole"" LosecMUPS®"
  • "Clarithromycin""Klacid®"

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One month after treatment

Other Outcome Measures

Outcome Measure
Time Frame
Compare the adverse reactions in each group
Time Frame: Three months
Three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Children's Hospital

Investigators

  • Principal Investigator: Xiwei Xu, MD, Beijing Children's Hosipital of Capital Medical University,China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Anticipated)

March 1, 2016

Study Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

November 25, 2015

First Submitted That Met QC Criteria

December 16, 2015

First Posted (Estimate)

December 18, 2015

Study Record Updates

Last Update Posted (Estimate)

December 18, 2015

Last Update Submitted That Met QC Criteria

December 16, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCH-HP-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Helicobacter Pylori Infection

Clinical Trials on Tailored Group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovakia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe