Oral Gut Liver Axis in Cirrhosis

NCT03030820 | Completed

• 1 other identifier: HM20006081
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cirrhosis; Periodontitis; Gingivitis

Keywords

cirrhosis; Periodontitis; oral health; gingivitis; inflammation

Outcome Measures

Primary Outcomes (1)

• Change in serum endotoxin

  Relative change in serum endotoxin levels using LAL (limulus amebocyte lysate) assay will be measured before/after cleaning and between groups

  30 days

Secondary Outcomes (6)

• Change in performance on two batteries of Cognitive function

  30 days

• Change in systemic inflammatory cytokines in the blood

  30 days

• All-cause Hospitalizations

  3 months

• Change in microbiota composition in the saliva and stool

  30 days

• MELD (model for end-stage liver disease) score change in the cirrhosis group

  30 days

Study Arms (1)

Dental cleaning

EXPERIMENTAL

Patients with cirrhosis and healthy controls will undergo dental examination and subsequent dental cleaning if necessary.

Procedure: Dental Cleaning

Interventions

Dental Cleaning PROCEDURE

This is standard of care dental cleaning as is guided by the initial dental evaluation

Dental cleaning

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Fibrosis; Periodontitis; Gingivitis; Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases

Study Officials

• Jasmohan Bajaj, MD

  VCU medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2017
• First Posted: January 25, 2017
• Study Start: October 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: April 4, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)