Oral Gut Liver Axis in Cirrhosis
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|ClinicalTrials.gov Identifier: NCT03030820|
Recruitment Status : Completed
First Posted : January 25, 2017
Last Update Posted : April 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cirrhosis Periodontitis Gingivitis||Procedure: Dental Cleaning||Not Applicable|
This will be a prospective study of cirrhotics and healthy controls comparing their oral microbiota, endotoxemia and systemic inflammation at baseline and at 10 and 30 days after clinically indicated systematic oral cleansing and interventions as well as 3-month hospitalizations post-cleaning.
The investigators will recruit cirrhotic subjects and age- matched healthy controls from the hepatology clinics. Subjects will be informed regarding the study and will give the investigators a written informed consent.
After informed consent and evaluation of eligibility, subjects will be asked to complete an oral health questionnaire and sample collection during the recruitment visit. Patients will then be scheduled for a dental exam during a separate screening visit up to 7 days after this recruitment visit at the Dental Clinics.
At this time patients will undergo cognitive testing consisting of a validated cognitive battery of PHES (psychometric hepatic encephalopathy score) and EncephalApp stroop. In addition, they will undergo Sickness Impact Profile (a quality of life questionnaire).
During dental exam which will be done during screening visit, the subject will undergo comprehensive oral evaluation which will include dental xrays (as needed) which are part of the study, periodontal examination (determination of pocket depth, clinical attachment levels, bleeding on probing, plaque index) and recording of caries and oral soft tissue lesions. Dental cleaning is part of the study protocol and not intended to fully treat the patient's periodontal and dental diseases. Therefore no follow-up dental visits will be scheduled in the dental clinics after completion of dental cleansing.
The patients who do not qualify for the study will be informed of the findings by the dental professionals and subsequently the patients need to make arrangements for their dental treatment needs.
The study will include cirrhotic patients with/without hepatic encephalopathy. Subjects will then be scheduled for dental cleaning which could occur over 1 or 2 visits as determined during the screening exam.
Before the initiation of oral therapy, plaque and gingival crevicular samples will be collected for microbiota. The subjects will receive deep dental cleanings (scaling and root planing) and oral hygiene instructions as per clinical indication.
Subjects will then be followed at day 10 for clinical exam and day 30 at which point stool, saliva and blood samples for the similar analyses as before will be collected. There will be no more dental examinations after the initial assessment and treatment. We will repeat the cognitive testing at day 30 using alternate forms of the same cognitive tests and also repeat quality of life testing at day 30 .
The investigators will also follow them for up to 3 months post-cleaning for hospitalizations using active chart review and follow-up
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Oral Gut Liver Axis in Cirrhosis|
|Study Start Date :||October 2016|
|Actual Primary Completion Date :||March 2018|
|Actual Study Completion Date :||March 2018|
Experimental: Dental cleaning
Patients with cirrhosis and healthy controls will undergo dental examination and subsequent dental cleaning if necessary.
Procedure: Dental Cleaning
This is standard of care dental cleaning as is guided by the initial dental evaluation
- Change in serum endotoxin [ Time Frame: 30 days ]Relative change in serum endotoxin levels using LAL (limulus amebocyte lysate) assay will be measured before/after cleaning and between groups
- Change in performance on two batteries of Cognitive function [ Time Frame: 30 days ]Relative change in PHES battery (total standard deviations above normal performance)and EncephalApp Stroop values (seconds taken) will be measured before/after cleaning and between groups
- Change in systemic inflammatory cytokines in the blood [ Time Frame: 30 days ]Relative change in pg/ml of serum IL-6 (interleukin), IL-1b (interleukin) using ELISA assays will be measured before/after cleaning and between groups
- All-cause Hospitalizations [ Time Frame: 3 months ]All-cause, liver-related and elective hospitalizations at 3 months will be studied and compared between groups
- Change in microbiota composition in the saliva and stool [ Time Frame: 30 days ]Relative change in microbial composition using 16SrRNA multi-tagged sequencing in stool and saliva will be measured before/after cleaning and between groups
- MELD (model for end-stage liver disease) score change in the cirrhosis group [ Time Frame: 30 days ]Relative change in MELD score will be analyzed in cirrhotic patients before/after cleaning
- Quality of life changes [ Time Frame: 30 days ]Changes in quality of life using Sickness Impact Profile will be measured
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03030820
|United States, Virginia|
|Virginia Commonwealth University|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Jasmohan Bajaj, MD||VCU medical Center|