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. - NI

MicrobioTx Health Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年7月22日

试验速览

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•Hepatic steatosis with ultrasound elastography or with liver biopsy (Stage 1/2/3/4)
•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).

•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

发起方

MicrobioTx Health Private Limited