Oral Gut Liver Axis in Cirrhosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Change in serum endotoxin
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •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
- •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.
研究组 & 干预措施
Dental cleaning
Patients with cirrhosis and healthy controls will undergo dental examination and subsequent dental cleaning if necessary.
干预措施: Dental Cleaning (Procedure)
结局指标
主要结局
Change in serum endotoxin
时间窗: 30 days
Relative change in serum endotoxin levels using LAL (limulus amebocyte lysate) assay will be measured before/after cleaning and between groups
次要结局
- 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)
- Quality of life changes(30 days)