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NCT00212225 · ClinicalTrials.gov registry record
Risk Factors for Gastric Disease in Pediatric Helicobacter Pylori (H. Pylori)
A clinical trial of Gastritis and Peptic Ulcer, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- 755
- Enrollment target
- 3
- Study locations
NCT00212225: Completed study of Gastritis and Peptic Ulcer, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT00212225 is a study of Gastritis and Peptic Ulcer that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 755 participants. The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00212225, a study of Gastritis and Peptic Ulcer, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- 755 participants
- Enrollment target
- 3
- Study locations
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 |
What the finished NCT00212225 record still lists
NCT00212225 is an observational study that tracks outcomes without assigning an intervention. The registered 755 participants enrollment target is mid-sized for trials with a published cap.
The record links to 3 conditions, with Gastritis appearing as the primary indexed condition, and to 0 interventions.
NCT00212225 reports a single indexed study location in Florida, Georgia, Ohio.
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.
Who is sponsoring clinical trial NCT00212225?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
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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