Oral H. Pylori Prevalence in Intellectually & Developmentally Disabled Adults
Condition: Helicobacter Pylori Infection
Study type: Observational

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 gastric infections is found in the mouth it may be swallowed and
      contribute to gastric infections.
    

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.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A study involving 110 intellectually disabled and/or developmentally disabled (ID/DD)
        participants aged 18 to 90 years of age at a facility in Kentucky will be conducted. An age
        and gender matched control group (n = 110) will also be evaluated for oral H. pylori
        prevalence and H. pylori gastric infections. The control group will be recruited and
        enrolled from the general dental clinics at the University of Louisville School of
        Dentistry.
      
Biospecimen description: 
      Samples of dental plaque.
    
Keywords: Helicobacter pylori; Oral Health; Intellectually & Developmentally Disabled