Oral H. Pylori Prevalence in Intellectually & Developmentally Disabled Adults

NCT ID: NCT00841490

Last Updated: 2017-04-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 220 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2012-05-31

Brief Summary

The purpose of this study is to determine if the bacteria that cause gastric infections can be found in the mouths of intellectually and developmentally disabled persons. If the bacteria that causes gastric infections is found in the mouth it may be swallowed and contribute to gastric infections.

Detailed Description

Helicobacter pylori (H. pylori) bacteria play a significant role in the etiology of gastric and duodenal ulcers, gastro-esophageal reflux disease and gastric adenocarcinoma. Intellectually disabled/developmentally disabled (ID/DD) adults are reported to have H. pylori infection at approximately twice the rate of the general population and experience recurrence at a seven-fold higher rate, contributing to increased mortality due to gastric cancer. The oral cavity may serve as a reservoir for H. pylori and subsequently contribute to the recurrence of gastric infection.

Numerous studies have identified H. pylori in dental plaque, an environment that is relatively resistant to systemic antibiotics. Systemic antibiotics are used to treat H. pylori infections but do not appear to eradicate H. pylori in the mouth. The oral status of ID/DD adults is reported to be poor due to inadequate oral hygiene, leading to increased plaque, caries and periodontal disease. Furthermore, poor oral status (periodontal disease) has been associated with H. pylori seropositivity. While ID/DD adults have elevated rates of H. pylori gastric infections, nothing is known about the prevalence of H. pylori in their oral cavities.

The proposed exploratory research will address the following questions in this disadvantaged population: 1) What is the prevalence of H. pylori in the dental plaque in ID/DD adults?, 2) Is poor oral status associated with H. pylori gastric infection?, and 3) Does H. pylori persist in the dental plaque of ID/DD adults after systemic antibiotic treatment, and if so, is it associated with recurrence of gastric infection? This epidemiological study of 112 institutionalized ID/DD and 112 control subjects will involve oral examinations, indices, dental plaque sampling, and C13 Urea Breath Tests at baseline to determine prevalence. Nested Polymerase Chain Reaction (PCR) analyses will be used to detect H. pylori in the dental plaque. For those ID/DD subjects who have a positive gastric H. pylori test at baseline, repeated oral sampling and gastric tests will be performed over 1 year to determine persistence.

If poor oral health status and oral H. pylori prevalence are correlated with gastric H. pylori infections, a future pilot clinical trial will be conducted to investigate the concordance between genetic strains of H. pylori in the mouth and stomach, the effect of various interventions on oral health, oral H. pylori prevalence, and H. pylori gastric infections in ID/DD adults. The proposed research responds to the Surgeon General's National Call to Action to conduct studies to elucidate underlying mechanisms and determine any causal associations between oral infections and systemic conditions. The proposed research also addresses the need to reduce health disparities, improve quality of life, and reduce morbidity and mortality in vulnerable populations.

Conditions

Helicobacter Pylori Infection

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

1

Intellectually \& Developmentally Disabled Adults

No interventions assigned to this group

2

Control Group of Adults without Intellectual \& Developmental Disabilities

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

ID/DD participants:

1. Mild, moderate, or severe intellectual and/or developmental disability (IQ < 50).

2. Dependent in two or more Activities of Daily Living.\

3. Unable to perform adequate oral hygiene.

4. At least six teeth present in the oral cavity including 6 posterior teeth present

Control Group Participants:

1. At least 6 posterior teeth present, and

2. Age and gender match to an ID/DD subject.

Exclusion Criteria

1. Antibiotics taken 2 weeks prior to baseline.

2. Proton pump inhibitors taken 2 weeks prior to baseline.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Dental and Craniofacial Research (NIDCR)

NIH

Sponsor Role: collaborator

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Catherine J Binkley

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Catherine J. Binkley, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

University of Louisville School of Dentistry

Louisville, Kentucky, United States

Bluegrass Oakwood

Somerset, Kentucky, United States

Countries

United States

Other Identifiers

1R21DE017378-01A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

OGMB080062

Identifier Type: -

Identifier Source: org_study_id