Oral Gut Liver Axis in Cirrhosis
Completed · Not applicable
Conditions studied: Cirrhosis, Periodontitis, Gingivitis
In brief
This will be a prospective study of cirrhotics and healthy controls comparing their oral microbiota, endotoxemia and systemic inflammation at baseline and at 30 days after clinically indicated systematic oral cleansing and interventions as well as 3-month hospitalizations post-cleaning.
Key facts
- Study ID
- NCT03030820
- Run by
- Virginia Commonwealth University
- People needed
- 44
- Starts
- 2016-10-01
- Expected to finish
- 2018-03-01
- Last updated by the study team
- 2018-04-04
Who can join
Age: 21 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Cirrhotic subjects:
- Age 21-75 years
- Able to give informed consent
- Cirrhosis diagnosed using biopsy or suggestive radiological features or endoscopic evidence of varices in a subject with chronic liver disease
- Healthy controls:
- Age 21-75 years
- Able to give informed consent
- Without chronic diseases
You may not qualify if…
- Exclusions for all subjects (will be done at the screening visit at both clinics)
- Current use of absorbable antibiotics (use of antibiotics within 4 weeks)
- Diagnosed with severe chronic or aggressive forms of periodontitis based on American Academy of Periodontology Classification (5)
- Presence of more than 2 severe cavitated caries lesions
- Presence of oral soft-tissue lesions such as ulcers
- Presence of abscesses
- Unclear diagnosis of cirrhosis (for cirrhotics)
- Edentulous or less than 20 natural teeth
- Smoking, oral tobacco and alcohol abuse within 3 months
- Prisoners
- Pregnant women
- INR(international normalized ratio) >1.5
- Platelet count <50,000
- Diagnosed bleeding disorders
- Patients on anti-coagulation
- Patients who will otherwise be eligible for prophylactic antibiotics before dental cleaning
- Last dental cleaning within 3 months of study.
Where it is running
- Virginia Commonwealth University — Richmond, Virginia, United States
Full record on ClinicalTrials.gov
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