Resistance of Helicobacter Pylori to Antibiotics in Children

Children Clinical Trial

Official title:

Resistance of Helicobacter Pylori to Antibiotics in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01902589
• Other study ID #: 0058-10-EMC
• Status: Completed
• Phase: N/A
• First received: September 27, 2011
• Last updated: August 30, 2015
• Start date: December 2010
• Est. completion date: October 2014

Study information

• Verified date: August 2015
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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 3.0 density of a bacterial suspension. Reading the susceptibility will take place following 72 hours of incubation in a micro aerophilic atmosphere.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: October 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 18 Years

Eligibility

Inclusion Criteria:

• ages of 1-18 years,

• evaluated for recurrent abdominal pain,

• iron deficiency anemia,

• failure to thrive by an upper endoscopy

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Abdominal Pain
• Antibiotic Resistant Strain
• Bacterial Infection Due to Helicobacter Pylori (H. Pylori)
• Bacterial Infections
• Children

Intervention

Other:
• Helicobacter Pylori Culture
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 3.0 density of a bacterial suspension. Reading the susceptibility will take place following 72 hours of incubation in a micro aerophilic atmosphere.

Locations

Country	Name	City	State
Israel	Ha'Emek Medical Center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resistance of specific organism to antibiotics		Two weeks from the culture	No