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临床试验/NCT00841490
NCT00841490已完成不适用

Oral H. Pylori Prevalence in Intellectually & Developmentally Disabled Adults

University of Louisville2 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2008年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
220
试验地点
2
主要终点
Prevalence of H. pylori in dental plaque

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 未提供

结局指标

主要结局

Prevalence of H. pylori in dental plaque

时间窗: one year

次要结局

  • Association of oral health status and/or oral H. pylori with H. pylori gastric infection(one year)
  • Persistence of H. pylori in the dental plaque of ID/DD adults after systemic antibiotic treatment(one year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Catherine J Binkley

Associate Professor

University of Louisville

研究点 (2)

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