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Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00212225 |
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 some individuals develop symptomatic disease is unclear and, until recently, no studies critically evaluated the role of pediatric Hp strains and/or host factors in disease outcomes. Over the past 5 years of National Institutes of Health (NIH) funding, 486 children from Atlanta, Cleveland, and Miami were enrolled; 184 (38%) were Hp-infected. Race (African American) and younger age, in conjunction with Hp strains expressing cagA and vacAs1B, were shown to be risk factors for both esophageal and gastric disease, suggesting a different disease paradigm from Hp-infected adults. Using the updated Sydney system, the investigators demonstrated a histopathologic spectrum in children, which included novel observations of atrophic gastritis with intestinal metaplasia. Overall hypothesis for competitive renewal: disease manifestations in Hp-infected children are influenced by specific host factors (i.e., race, immune phenotype), environmental exposures, and specific virulence factors of infecting Hp strains.
Specific aims:
Hp-infected symptomatic endoscopy cases at the investigators' established 3 clinical centers of high, moderate and low Hp prevalence will be compared with age-matched Hp-infected asymptomatic and uninfected symptomatic controls. Two geographically and demographically distinct centers have been added to provide additional geographic and subject representativeness to the patient cohort. The updated Sydney system will be employed to assess gastric histopathology severity and phenotype in newly enrolled cases in specific age, gender and demographic strata and follow-up of the two "novel" cohorts established in the past 5 years: a) atrophic gastritis; and b) esophageal and gastric disease groups enabling a comprehensive, multivariate evaluation of the natural history of Hp-infected children in two distinct disease paradigms.
Using molecular methods (multiplex [MP]-PCR, RT-PCR) and a micro ELISPOT assay on peripheral blood mononuclear cells (PBMCS), Th1, Th2, Th3 or balanced Th1/Th2 response will be determined to further characterize the Hp-infected child's immune response phenotype. The investigators propose to further their previous work with critically lacking studies from a multivariate approach, leading to a better understanding of the gastroduodenal disease sequelae and overall pathobiology of Hp infection in humans.
Condition |
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Helicobacter Infections Gastritis Peptic Ulcer |
Study Type: | Observational |
Official Title: | Risk Factors for Gastric Disease in Pediatric H. Pylori |
Estimated Enrollment: | 755 |
Study Start Date: | October 1997 |
Study Completion Date: | December 2007 |
Ages Eligible for Study: | 6 Months to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Using the power determinations for age, gender and demographic characteristics, the investigators will screen all patients undergoing diagnostic upper endoscopy at:
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:
Exclusion Criteria:
United States, Florida | |
Miami Children's Hospital; Division of Pediatric Gastroenterology | |
Miami, Florida, United States, 33105 | |
United States, Georgia | |
Emory University School of Medicine; Emory Children's Center | |
Atlanta, Georgia, United States, 30322 | |
United States, Ohio | |
Case Western Reserve University; Rainbow Babies and Children's Hospital | |
Cleveland, Ohio, United States, 44106 |
Principal Investigator: | Benjamin D. Gold, M.D. | Emory University |
Study ID Numbers: | DK53708 |
Study First Received: | September 20, 2005 |
Last Updated: | December 14, 2007 |
ClinicalTrials.gov Identifier: | NCT00212225 History of Changes |
Health Authority: | United States: Federal Government |
gastric disease H. pylori children |
Helicobacter pylori child epidemiology |
Bacterial Infections Digestive System Diseases Stomach Diseases Gastrointestinal Diseases Ulcer Helicobacter Infections |
Intestinal Diseases Gastroenteritis Gastritis Duodenal Diseases Peptic Ulcer Gram-Negative Bacterial Infections |
Bacterial Infections Digestive System Diseases Stomach Diseases Gastrointestinal Diseases Helicobacter Infections Intestinal Diseases |
Gastroenteritis Infection Gastritis Duodenal Diseases Peptic Ulcer Gram-Negative Bacterial Infections |