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
|Condition or disease||Intervention/treatment||Phase|
|Helicobacter Pylori Infection||Drug: Tailored Group Drug: Standard group||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
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) .
- 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.
- Compare the adverse reactions in each group [ Time Frame: Three months ]
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
|Contact: Xiwei Xu, MDfirstname.lastname@example.org|
|Principal Investigator:||Xiwei Xu, MD||Beijing Children's Hosipital of Capital Medical University,China|