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Trial record 5 of 343 for:    Open Studies | "Anti-Bacterial Agents"

Resistance of Helicobacter Pylori to Antibiotics in Children

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by HaEmek Medical Center, Israel
Sponsor:
Information provided by (Responsible Party):
Dr Koren Ariel, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT01902589
First received: September 27, 2011
Last updated: July 16, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Abdominal Pain
Children
Bacterial Infection Due to Helicobacter Pylori (H. Pylori)
Antibiotic Resistant Strain
Other: Helicobacter Pylori Culture

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Resistance of Helicobacter Pylori to Antibiotics in Children

Resource links provided by NLM:


Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • Resistance of specific organism to antibiotics [ Time Frame: Two weeks from the culture ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: December 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with Helicobacter pilorii in biopsy
Patients with Helicobacter pylori in biopsy, cultures will be obtained and subsequently sensitivity to antibiotics studied.
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.


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

  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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.

Criteria

Inclusion Criteria:

  • ages of 1-18 years,
  • evaluated for recurrent abdominal pain,
  • iron deficiency anemia,
  • failure to thrive by an upper endoscopy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01902589

Contacts
Contact: Sarit Peleg, MD 972-4-6494104 ext 4104 peleg_sa@clalit.org.il

Locations
Israel
Ha'Emek Medical Center Recruiting
Afula, Israel, 18101
Contact: Sarit Peleg, MD    972-4-6494104 ext 4104    peleg_sa@clalit.org.il   
Sub-Investigator: Rasha Haliliah, MD         
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Principal Investigator: Sarit Peleg, MD Ha'Emek Medical Center, Afula, Israel
  More Information

No publications provided

Responsible Party: Dr Koren Ariel, Head of Pediatric Dpt B, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT01902589     History of Changes
Other Study ID Numbers: 0058-10-EMC
Study First Received: September 27, 2011
Last Updated: July 16, 2013
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Abdominal Pain
Bacterial Infections
Pain
Signs and Symptoms
Signs and Symptoms, Digestive
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014