Risk Factors for Gastric Disease in Pediatric Helicobacter Pylori (H. Pylori)

NCT00212225 | Completed

• 1 other identifier: DK53708 (completed)
• Study Type: observational
• Target: 755
• Locations: 1 country
• Sites: 3

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 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. 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. 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. 3.Further characterize the host immunologic and mucosal response in Hp-infected children.

Conditions

Helicobacter Infections; Gastritis; Peptic Ulcer

Keywords

gastric disease; H. pylori; children; Helicobacter pylori; child; epidemiology

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (3)

Miami Children's Hospital; Division of Pediatric Gastroenterology

Miami, Florida, 33105, United States

Location

Emory University School of Medicine; Emory Children's Center

Atlanta, Georgia, 30322, United States

Location

Case Western Reserve University; Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Helicobacter Infections; Gastritis; Peptic Ulcer; Stomach Diseases

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Duodenal Diseases; Intestinal Diseases

Study Officials

• Benjamin D. Gold, M.D.

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 20, 2005
• First Posted: September 21, 2005
• Study Start: October 1, 1997
• Study Completion: December 1, 2007
• Last Updated: January 13, 2010

Record last verified: 2010-01

Locations

US (3)