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Risk Factors for Gastric Disease in Pediatric Helicobacter Pylori (H. Pylori)
NCT00212225 · View on ClinicalTrials.gov ↗
Study 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 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
Conditions Studied
Study Locations (3)
Florida
- Miami Children's Hospital; Division of Pediatric Gastroenterology — Miami
Georgia
- Emory University School of Medicine; Emory Children's Center — Atlanta
Ohio
- Case Western Reserve University; Rainbow Babies and Children's Hospital — Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 755 participants |
| Start Date | 1997-10 |
| Est. Completion | 2007-12 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00212225
The ClinicalTrials.gov registry entry for NCT00212225 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 755 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 375 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Gastritis appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00212225 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Florida, Georgia, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00212225 about?
NCT00212225 is a clinical study titled "Risk Factors for Gastric Disease in Pediatric Helicobacter Pylori (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 ...
What is the current status of trial NCT00212225?
This trial is currently completed. The enrollment target is 755 participants. The study started on 1997-10. Estimated completion is 2007-12.
What conditions does trial NCT00212225 study?
This clinical trial studies the following conditions: Gastritis, Peptic Ulcer, Helicobacter Infections. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT00212225?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 375 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00212225 being conducted?
This trial has 3 study locations across Florida, Georgia, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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