Concordance of gut health profile built using blood test and stool test for patients with non-alcoholic fatty liver disease

Not Applicable

• Conditions: Health Condition 1: E638- Other specified nutritional deficiencies

• Registration Number: CTRI/2024/06/069462
• Lead Sponsor: MicrobioTx Health Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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) <br/ ><br>and <br/ ><br>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 Outcome Measures

Name	Time	Method
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. <br/ ><br>