Status:
COMPLETED
Risk Factors for Gastric Disease in Pediatric Helicobacter Pylori (H. Pylori)
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Helicobacter Infections
Gastritis
Eligibility:
All Genders
6-18 years
Brief Summary
Helicobacter pylori (Hp) is a major cause of chronic-active gastritis and primary duodenal ulcers, and is strongly linked to gastric cancer. Most Hp infections worldwide are acquired in childhood. Why...
Detailed Description
Discovered in 1982 as a cause of gastroduodenal ulceration, Helicobacter pylori (Hp) is the major cause of gastritides (e.g. chronic-active) and primary duodenal ulcers in adults and children. \[Warre...
Eligibility Criteria
Inclusion
- Using the power determinations for age, gender and demographic characteristics, the investigators will screen all patients undergoing diagnostic upper endoscopy at:
- Children's Healthcare of Atlanta (Egleston and Scottish Rite Children's Hospitals), Atlanta, GA
- Rainbow Babies and Children's Hospital, Cleveland, OH
- Miami Children's Hospital, Miami, FL.
- Patients will be enrolled over the first 3 years of the study, and then based on interim univariate analysis. The investigators also will perform follow-up evaluations (i.e., clinically-indicated) on the two novel cohorts identified during the first 5 years of funding:
- the atrophic gastritis Hp-infected cohort
- the esophagitis/gastritis cohort, in order to assess the natural history of gastroduodenal inflammation in the Hp-infected child.
Exclusion
- Patients who have taken antibiotics within one month of endoscopy will be excluded, as preceding antibiotic therapy will confound ability to determine Hp infection status.
- In the previous five years, the investigators initially eliminated children taking proton pump inhibitors (PPIs) (e.g., omeprazole); Na+/H+ ATPase channel inhibitors. PPIs have a minimum inhibitory concentration (MIC) against Hp in vitro, and therefore may reduce the overall bacterial load, diminishing the ability to detect infection, and resolve gastroduodenal mucosal inflammation, confounding characterization of cellular host response to Hp infection. However, due to the pervasive use of PPIs in the pediatric population, and the exclusion of potential cases, the investigators improved their culture sensitivity techniques and are able to successfully detect the organism in the setting of a child on a PPI. This will be taken into account when characterizing the gastric mucosal inflammatory phenotype and comparative analyses are performed.
Key Trial Info
Start Date :
October 1 1997
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
755 Patients enrolled
Trial Details
Trial ID
NCT00212225
Start Date
October 1 1997
End Date
December 1 2007
Last Update
January 13 2010
Active Locations (3)
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1
Miami Children's Hospital; Division of Pediatric Gastroenterology
Miami, Florida, United States, 33105
2
Emory University School of Medicine; Emory Children's Center
Atlanta, Georgia, United States, 30322
3
Case Western Reserve University; Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106