Health Condition 1: E638- Other specified nutritional deficiencies
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
MicrobioTx Health Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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).
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) and 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)Timepoint: The single time point at which the data will be analysed will be 26 weeks from the start of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Design probiotic formulation to improve gut health in NAFLD patientsTimepoint: The single time point at which the data will be analysed will be 1 year from the start of the study. | — |
Countries
India
Contacts
Public ContactDr Palok Aich
MicrobioTx Health Private Limited
Outcome results
None listed