Oral H. Pylori Prevalence in Intellectually & Developmentally Disabled Adults

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by University of Louisville.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
University of Louisville
ClinicalTrials.gov Identifier:
NCT00841490
First received: February 9, 2009
Last updated: June 1, 2010
Last verified: May 2010
  Purpose

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.


Condition
Helicobacter Pylori Infection

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Oral H. Pylori Prevalence in Intellectually & Developmentally Disabled Adults

Resource links provided by NLM:


Further study details as provided by University of Louisville:

Primary Outcome Measures:
  • Prevalence of H. pylori in dental plaque [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Association of oral health status and/or oral H. pylori with H. pylori gastric infection [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Persistence of H. pylori in the dental plaque of ID/DD adults after systemic antibiotic treatment [ Time Frame: one year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Samples of dental plaque.


Estimated Enrollment: 220
Study Start Date: September 2008
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Intellectually & Developmentally Disabled Adults
2
Control Group of Adults without Intellectual & Developmental Disabilities

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00841490

Locations
United States, Kentucky
University of Louisville School of Dentistry
Louisville, Kentucky, United States, 40202
Bluegrass Oakwood
Somerset, Kentucky, United States, 42501
Sponsors and Collaborators
University of Louisville
Investigators
Principal Investigator: Catherine J. Binkley, DDS, PhD University of Louisville
  More Information

No publications provided

Responsible Party: Catherine J. Binkley, University of Louisville
ClinicalTrials.gov Identifier: NCT00841490     History of Changes
Other Study ID Numbers: OGMB080062, DE017378
Study First Received: February 9, 2009
Last Updated: June 1, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Louisville:
Helicobacter pylori
Oral Health
Intellectually & Developmentally Disabled

Additional relevant MeSH terms:
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on September 18, 2014