Ignite Creation Date:
2024-05-06 @ 7:55 AM
Last Modification Date:
2024-10-26 @ 11:54 AM
Study NCT ID:
NCT02635191
Status:
UNKNOWN
Last Update Posted:
2015-12-18
First Post:
2015-11-25
Brief Title:
Tailored Therapy for Helicobacter Pylori in Children
Sponsor:
Beijing Childrens Hospital
Organization:
Beijing Childrens Hospital
Study Overview
Official Title:
Tailored Therapy Versus Standard Triple Therapy for Helicobacter Pylori Eradication in Children A Randomized Trial
Status:
UNKNOWN
Status Verified Date:
2015-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is designed to compare the eradication ratessafety 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 HospitalAfter the informed consents are obtained from the guardians the children will be randomly classified into the two group 10 days standard triple therapy Omeprazole 08-10mgkgdbid Amoxicillin 30-50mgkgd bid Clarithromycin 15-20mgkgd bid or 10 days tailored therapy including one Proton Pump Inhibitor Rabeprazole 04-05mgkgdbid or Esomeprazole 08-10mgkgdbid and two antibiotics Amoxicillin 30-50mgkgd bid Clarithromycin 15-20mgkgd bid Metronidazole15-20mgkgd bid based on antibiotics susceptibility and cytochrome P450 isoenzyme 2C19 genotype Eradication status will be reassessed in four weeks after treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None