Oral H. Pylori Prevalence in Intellectually & Developmentally Disabled Adults
研究概览
地位
条件
详细说明
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.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Kentucky
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Louisville、Kentucky、美国、40202
- University of Louisville School of Dentistry
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Somerset、Kentucky、美国、42501
- Bluegrass Oakwood
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
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.
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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1
Intellectually & Developmentally Disabled Adults
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2
Control Group of Adults without Intellectual & Developmental Disabilities
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Prevalence of H. pylori in dental plaque
大体时间:one year
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one year
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次要结果测量
结果测量 |
大体时间 |
---|---|
Association of oral health status and/or oral H. pylori with H. pylori gastric infection
大体时间:one year
|
one year
|
Persistence of H. pylori in the dental plaque of ID/DD adults after systemic antibiotic treatment
大体时间:one year
|
one year
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合作者和调查者
调查人员
- 首席研究员:Catherine J. Binkley, DDS, PhD、University of Louisville
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- OGMB080062
- 1R21DE017378-01A2 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
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