Identify microbial and metabolic biomarkers for early detection of Non-alcoholic fatty liver disease (NAFLD) using Gut Function Test (GFT), and to study longitudinal impact of probiotics.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Sensitivity: Sensitivity is defined as (the number of microbes called within normal range by both the standard of care and MicrobioTx)/(number of microbes called within normal range by the standard of care)
研究概览
简要总结
The major theme of the current proposal is to develop high-throughput, sensitive, and rapid metabolomic (MS/MS), and metagenomic (fecal microbiome) methodologies to establish metabolite (from serum) and microbial (from fecal samples) markers in human patients to differentially identify the various stages types of NAFLD/NASH/Cirrhosis to detect the early disease onset. Metabolite markers are sensitive to the femtomolar (10-15 M, millionth of a billionth) level, so even a single marker for a disease could be potent enough to detect the onset of a disease. The biomarkers in most cases will consist of a group of metabolites instead of one so the detection power would be even higher. The abundance of a group of biomarkers could also be helpful in enhancing the detection limit. In addition, the metabolite markers will also correlate with a group of gut microbiomes that may be absent or present in a disease condition and can serve as a potential probiotic for intervention. This potential probiotic could be individualized to develop personalized probiotic supplements. Selected and identified biomarkers may also be utilized to develop colorimetric assay kits using blood and fecal samples from individuals.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 59.00 Year(s)（—）
- 性别
- All
入选标准
- •Hepatic steatosis with ultrasound elastography or with liver biopsy (Stage 1/2/3/4) Mild NAFLD Moderate NAFLD Severe NAFLD without Cirrhosis Severe NAFLD with Cirrhosis All outpatients aged 18-59 years presenting with NAFLD with various conditions (as described) as per standard definitions belong to any groups above.
- •The diagnosis of NAFLD currently requires: (1) evidence of hepatic steatosis (HS) by imaging or histology, (2) no significant alcohol consumption, (3) no competing causes of HS, and (4) no coexisting causes of chronic liver disease.
- •Patients who have normal general health and normal findings on clinical history, physical examination, blood count, and have ultrasonographic evidence of fatty liver with no other abnormal clinical or ultrasonographic findings will be included in this study.
- •For NAFLD patients with T2DM &;/or Obesity, we will recruit a) Patients with a diagnosis of T2DM (International Classification of Diseases (ICD-11 that was adopted by the 72 nd World Health Assembly in 2019 and will come into effect on 1 st January 2022) following codes 5A11 which was updated from ICD-10 codes E11, E11.0-E11.9, E14, and E14.0-E14.9) as of 31 December 2016 (index date).
排除标准
- •Any active illness, psychological and/or pathological condition that would interfere with study participation in the opinion of the Investigator Participants with a history of alcohol consumption exceeding 20 grams per day (both male and female) Participants taking immunosuppressants, tamoxifen, amiodarone and/or perhexiline; Currently following a weight loss diet Those who have other known liver diseases (hepatitis viruses A through E, autoimmune disease, Wilson’s disease).
- •Those who are on drugs, which are likely to induce fatty liver or insulin sensitization.
- •Require daytime ventilation assistance.
结局指标
主要结局
Sensitivity: Sensitivity is defined as (the number of microbes called within normal range by both the standard of care and MicrobioTx)/(number of microbes called within normal range by the standard of care)
时间窗: The single time point at which the data will be analysed will be 26 weeks from the start of the study.
and
时间窗: The single time point at which the data will be analysed will be 26 weeks from the start of the study.
Specificity: Specificity is defined as (number of microbes called deficient by both the standard of care and by MicrobioTx)/(number of microbes called deficient by standard of care)
时间窗: The single time point at which the data will be analysed will be 26 weeks from the start of the study.
次要结局
- Design probiotic formulation to improve gut health in NAFLD patients(The single time point at which the data will be analysed will be 1 year from the start of the study.)
研究者
Dr Palok Aich
MicrobioTx Health Private Limited