Peptic Ulcer Clinical Trial
Official title:
Risk Factors for Gastric Disease in Pediatric H. Pylori
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:
1. Using well defined cases and controls, further characterize specific host factors and
environmental exposures contributing to symptomatic childhood infection emphasizing
targeted enrollment in specific age, gender and demographic strata to facilitate
detection of significant differences not attained previously and follow-up of 2
established specific cohorts to ascertain immune response natural history.
2. Utilize gene-array technology for the whole Hp genome assessment and bacterial gene
expression of specific virulence determinants associated with pediatric Hp strains.
3. Further characterize the host immunologic and mucosal response in Hp-infected children.
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.
Status | Completed |
Enrollment | 755 |
Est. completion date | December 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Months to 18 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
N/A
Country | Name | City | State |
---|---|---|---|
United States | Emory University School of Medicine; Emory Children's Center | Atlanta | Georgia |
United States | Case Western Reserve University; Rainbow Babies and Children's Hospital | Cleveland | Ohio |
United States | Miami Children's Hospital; Division of Pediatric Gastroenterology | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
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