Resistance of Helicobacter Pylori to Antibiotics in Children
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 115
- Locations
- 1
- Primary Endpoint
- Resistance of specific organism to antibiotics
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 1 Year to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •ages of 1-18 years,
- •evaluated for recurrent abdominal pain,
- •iron deficiency anemia,
- •failure to thrive by an upper endoscopy
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Resistance of specific organism to antibiotics
Time Frame: Two weeks from the culture
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr Koren Ariel
Head of Pediatric Dpt B
HaEmek Medical Center, Israel