Oral H. Pylori Prevalence in Intellectually & Developmentally Disabled Adults
Recruitment status was Active, not recruiting
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Purpose
| Condition |
|---|
|
Helicobacter Pylori Infection |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Oral H. Pylori Prevalence in Intellectually & Developmentally Disabled Adults |
- Prevalence of H. pylori in dental plaque [ Time Frame: one year ] [ Designated as safety issue: No ]
- Association of oral health status and/or oral H. pylori with H. pylori gastric infection [ Time Frame: one year ] [ Designated as safety issue: No ]
- Persistence of H. pylori in the dental plaque of ID/DD adults after systemic antibiotic treatment [ Time Frame: one year ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
| Estimated Enrollment: | 220 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | June 2010 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
Intellectually & Developmentally Disabled Adults
|
|
2
Control Group of Adults without Intellectual & Developmental Disabilities
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
ID/DD participants:
- Mild, moderate, or severe intellectual and/or developmental disability (IQ < 50).
- Dependent in two or more Activities of Daily Living.\
- Unable to perform adequate oral hygiene.
- At least six teeth present in the oral cavity including 6 posterior teeth present
Control Group Participants:
- At least 6 posterior teeth present, and
- Age and gender match to an ID/DD subject.
Exclusion Criteria (Both Groups):
- Antibiotics taken 2 weeks prior to baseline.
- Proton pump inhibitors taken 2 weeks prior to baseline.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00841490
| United States, Kentucky | |
| University of Louisville School of Dentistry | |
| Louisville, Kentucky, United States, 40202 | |
| Bluegrass Oakwood | |
| Somerset, Kentucky, United States, 42501 | |
| Principal Investigator: | Catherine J. Binkley, DDS, PhD | University of Louisville |
More Information
| Responsible Party: | Catherine J. Binkley, University of Louisville |
| ClinicalTrials.gov Identifier: | NCT00841490 History of Changes |
| Other Study ID Numbers: | OGMB080062 DE017378 |
| Study First Received: | February 9, 2009 |
| Last Updated: | June 1, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Louisville:
|
Helicobacter pylori Oral Health Intellectually & Developmentally Disabled |
Additional relevant MeSH terms:
|
Helicobacter Infections Gram-Negative Bacterial Infections Bacterial Infections |
ClinicalTrials.gov processed this record on September 30, 2016