CirrhosisNCT03030820
Oral Gut Liver Axis in Cirrhosis
A study testing Dental Cleaning in people with Cirrhosis and Periodontitis, run by Virginia Commonwealth University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cirrhosis, Periodontitis, Gingivitis
- What is being tested?
- Dental Cleaning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
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.
Read the detailed description
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
- Conditions
- Cirrhosis, Periodontitis, Gingivitis
- Being tested
- Dental Cleaning
- Keywords
- cirrhosis, Periodontitis, oral health, gingivitis, inflammation
- Medical subject headings
- Fibrosis, Periodontitis, Gingivitis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental CleaningProcedure or surgery
This is standard of care dental cleaning as is guided by the initial dental evaluation
| Study group | Role | What they receive |
|---|---|---|
| Dental cleaning | Experimental | Patients with cirrhosis and healthy controls will undergo dental examination and subsequent dental cleaning if necessary. Receives: Procedure: Dental Cleaning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Secondary outcomes (6)
Change in performance on two batteries of Cognitive function
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
Measured: 30 days
Change in systemic inflammatory cytokines in the blood
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
Measured: 30 days
All-cause Hospitalizations
All-cause, liver-related and elective hospitalizations at 3 months will be studied and compared between groups
Measured: 3 months
Change in microbiota composition in the saliva and stool
Relative change in microbial composition using 16SrRNA multi-tagged sequencing in stool and saliva will be measured before/after cleaning and between groups
Measured: 30 days
MELD (model for end-stage liver disease) score change in the cirrhosis group
Relative change in MELD score will be analyzed in cirrhotic patients before/after cleaning
Measured: 30 days
Quality of life changes
Changes in quality of life using Sickness Impact Profile will be measured
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study startOct 2016
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jasmohan Bajaj, MD, Principal investigator, VCU medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03030820
- Sponsor's protocol ID
- HM20006081
- Status last verified
- Apr 2018
- First submitted
- 5 Jan 2017
- Last updated
- 4 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Gut Liver Axis in Cirrhosis
- ClinicalTrials.gov ID
- NCT03030820
- Acronym / sponsor ID
- HM20006081
- Conditions
- Cirrhosis, Periodontitis, Gingivitis
- Keywords
- cirrhosis, Periodontitis, oral health, gingivitis, inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 25 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dental cleaning | Experimental | Procedure: Dental CleaningPatients with cirrhosis and healthy controls will undergo dental examination and subsequent dental cleaning if necessary. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- Age 21-75 years
- Able to give informed consent
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental CleaningThis is standard of care dental cleaning as is guided by the initial dental evaluation | Procedure or surgery | Dental cleaning |
Primary outcome
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
6 secondary outcomes
Change in performance on two batteries of Cognitive function
Time frame: 30 days
Change in systemic inflammatory cytokines in the blood
Time frame: 30 days
All-cause Hospitalizations
Time frame: 3 months
Change in microbiota composition in the saliva and stool
Time frame: 30 days
MELD (model for end-stage liver disease) score change in the cirrhosis group
Time frame: 30 days
Quality of life changes
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jasmohan Bajaj, MD principal investigator
VCU medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental Cleaning in people with Cirrhosis and Periodontitis, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum endotoxin (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2018.