Resistance of Helicobacter Pylori to Antibiotics in Children

NCT01902589 | Completed

• 1 other identifier: 0058-10-EMC
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Resistance of specific organism to antibiotics

  Two weeks from the culture

Study Arms (1)

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

Interventions

Helicobacter Pylori Culture OTHER

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.

Patients with Helicobacter pilorii in biopsy

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• ages of 1-18 years,
• evaluated for recurrent abdominal pain,
• iron deficiency anemia,
• failure to thrive by an upper endoscopy

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (1)

Ha'Emek Medical Center

Afula, 18101, Israel

Location

MeSH Terms

Conditions

Abdominal Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Sarit Peleg, MD

  Ha'Emek Medical Center, Afula, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Pediatric Dpt B

Study Record Dates

• First Submitted: September 27, 2011
• First Posted: July 18, 2013
• Study Start: December 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: October 1, 2014
• Last Updated: September 1, 2015

Record last verified: 2015-08

Locations

IL (1)