Status:
COMPLETED
Oral H. Pylori Prevalence in Intellectually & Developmentally Disabled Adults
Lead Sponsor:
University of Louisville
Collaborating Sponsors:
National Institute of Dental and Craniofacial Research (NIDCR)
Conditions:
Helicobacter Pylori Infection
Eligibility:
All Genders
18-90 years
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 g...
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/de...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00841490
Start Date
September 1 2008
End Date
May 1 2012
Last Update
April 14 2017
Active Locations (2)
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1
University of Louisville School of Dentistry
Louisville, Kentucky, United States, 40202
2
Bluegrass Oakwood
Somerset, Kentucky, United States, 42501