Ignite Creation Date:
2024-05-06 @ 1:49 AM
Last Modification Date:
2024-10-26 @ 11:10 AM
Study NCT ID:
NCT01902589
Status:
COMPLETED
Last Update Posted:
2015-09-01
First Post:
2011-09-27
Brief Title:
Resistance of Helicobacter Pylori to Antibiotics in Children
Sponsor:
HaEmek Medical Center Israel
Organization:
HaEmek Medical Center Israel
Study Overview
Official Title:
Resistance of Helicobacter Pylori to Antibiotics in Children
Status:
COMPLETED
Status Verified Date:
2015-08
Last Known Status:
None
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:
Helicobacter Pylori HP is one of the most common pathogens in humans This infection can present in children with abdominal pain vomiting and iron deficiency The treatment is usually empiric and includes antibiotic treatment usually Amoxycillin and Clarithromycin or Metronidazole Between 40 to 70 of the pathogens are resistant to those drugs and it is important to characterize the specific sensitivity of the pathogens in any specific area and in pediatric population The aims of this study is to assess the sensitivity of HP in pediatric population in Northern Israel
Detailed Description:
The aim of our prospective study is to investigate the rate of H pylori resistant strains to antibiotic treatment including Amoxicillin Clarithromycin Metronidazole Tetracycline and Quinolones in pediatric population in Ha-Emek medical center Afula The second aim was to determine if in vitro resistance is being reflected in vivo too
Should the investigators find high rates of H pylori resistance to Clarithromycin the investigators will have to reconsider the recommendation to use Clarithromycin as the first line treatment for H pylori
Our research group will conclude 100 children in the ages of 1-18 years evaluated for recurrent abdominal pain iron deficiency anemia failure to thrive by an upper endoscopy biopsy specimens taken for a rapid urease test for histology for culture and for antibiotic susceptibility testing
Biopsy specimens for histology will be fixed in formalin embedded in paraffin and sectioned and stained with hematoxylin and eosin
The microbiological workup will include an imprint of the biopsy on a slide followed by a gram stain for the purpose of demonstrating H pylori in situ Further the biopsies will be streaked out on chocolate agar Sheep blood agar and H pylori selective agar supplemented with Polymixin to suppress possible contaminants
4 days of incubation in a micro aerophilic atmosphere will follow Susceptibility testing of H pylori will be performed with E test on Mueller Hinton agar supplemented with defibrinated sheep blood using a MacFalrland 30 density of a bacterial suspension Reading the susceptibility will take place following 72 hours of incubation in a micro aerophilic atmosphere
Should the investigators find high rates of H pylori resistance to Clarithromycin the investigators will have to reconsider the recommendation to use Clarithromycin as the first line treatment for H pylori
Our research group will conclude 100 children in the ages of 1-18 years evaluated for recurrent abdominal pain iron deficiency anemia failure to thrive by an upper endoscopy biopsy specimens taken for a rapid urease test for histology for culture and for antibiotic susceptibility testing
Biopsy specimens for histology will be fixed in formalin embedded in paraffin and sectioned and stained with hematoxylin and eosin
The microbiological workup will include an imprint of the biopsy on a slide followed by a gram stain for the purpose of demonstrating H pylori in situ Further the biopsies will be streaked out on chocolate agar Sheep blood agar and H pylori selective agar supplemented with Polymixin to suppress possible contaminants
4 days of incubation in a micro aerophilic atmosphere will follow Susceptibility testing of H pylori will be performed with E test on Mueller Hinton agar supplemented with defibrinated sheep blood using a MacFalrland 30 density of a bacterial suspension Reading the susceptibility will take place following 72 hours of incubation in a micro aerophilic atmosphere
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