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Tailored Therapy for Helicobacter Pylori in Children

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ClinicalTrials.gov Identifier: NCT02635191
Recruitment Status : Unknown
Verified November 2015 by Xiwei Xu, Beijing Children's Hospital.
Recruitment status was:  Recruiting
First Posted : December 18, 2015
Last Update Posted : December 18, 2015
Sponsor:
Information provided by (Responsible Party):
Xiwei Xu, Beijing Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: Tailored Group Drug: Standard group Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tailored Therapy Versus Standard Triple Therapy for Helicobacter Pylori Eradication in Children: A Randomized Trial
Study Start Date : March 2014
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : July 2016

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:
  • "Omeprazole"" LosecMUPS®"
  • "Amoxicillin""Tongdamoxing®"
  • "Clarithromycin""Klacid®"




Primary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Compare the adverse reactions in each group [ Time Frame: Three months ]


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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02635191


Contacts
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Contact: Xiwei Xu, MD 861059616308 xuxiweibch@163.com

Locations
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China
Recruiting
Beijing, China
Sponsors and Collaborators
Beijing Children's Hospital
Investigators
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Principal Investigator: Xiwei Xu, MD Beijing Children's Hosipital of Capital Medical University,China

Publications:

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Responsible Party: Xiwei Xu, Chief of Gastroenterology Department, Beijing Children's Hospital
ClinicalTrials.gov Identifier: NCT02635191     History of Changes
Other Study ID Numbers: BCH-HP-001
First Posted: December 18, 2015    Key Record Dates
Last Update Posted: December 18, 2015
Last Verified: November 2015

Keywords provided by Xiwei Xu, Beijing Children's Hospital:
Helicobacter pylori
Therapy
Children

Additional relevant MeSH terms:
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Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Amoxicillin
Metronidazole
Clarithromycin
Omeprazole
Esomeprazole
Rabeprazole
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors