Helicobacter Pylori Infection Clinical Trial
Official title:
Oral H. Pylori Prevalence in Intellectually & Developmentally Disabled Adults
Verified date | December 2016 |
Source | University of Louisville |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 220 |
Est. completion date | May 2012 |
Est. primary completion date | May 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
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 (Both Groups): 1. Antibiotics taken 2 weeks prior to baseline. 2. Proton pump inhibitors taken 2 weeks prior to baseline. |
Country | Name | City | State |
---|---|---|---|
United States | University of Louisville School of Dentistry | Louisville | Kentucky |
United States | Bluegrass Oakwood | Somerset | Kentucky |
Lead Sponsor | Collaborator |
---|---|
University of Louisville | National Institute of Dental and Craniofacial Research (NIDCR) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevalence of H. pylori in dental plaque | one year | ||
Secondary | Association of oral health status and/or oral H. pylori with H. pylori gastric infection | one year | ||
Secondary | Persistence of H. pylori in the dental plaque of ID/DD adults after systemic antibiotic treatment | one year |
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