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CTRI Number  CTRI/2024/06/069462 [Registered on: 25/06/2024] Trial Registered Prospectively
Last Modified On: 03/07/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Concordance of gut health profile built using blood test and stool test for patients with non-alcoholic fatty liver disease 
Scientific Title of Study   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. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Palok Aich 
Designation  Director 
Affiliation  MicrobioTx Health Private Limited 
Address  363, 8th Main, 3rd Block, Koramangala, Bangalore

Bangalore
KARNATAKA
560034
India 
Phone  9019343030  
Fax    
Email  hello@microbiotx.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Palok Aich 
Designation  Director 
Affiliation  MicrobioTx Health Private Limited 
Address  363, 8th Main, 3rd Block, Koramangala, Bangalore

Bangalore
KARNATAKA
560034
India 
Phone  9019343030  
Fax    
Email  hello@microbiotx.com  
 
Details of Contact Person
Public Query  
Name  Dr Palok Aich 
Designation  Director 
Affiliation  MicrobioTx Health Private Limited 
Address  363, 8th Main, 3rd Block, Koramangala, Bangalore

Bangalore
KARNATAKA
560034
India 
Phone  9019343030  
Fax    
Email  hello@microbiotx.com  
 
Source of Monetary or Material Support  
Infrastructure and clinical support provided by Aster CMI Hospital to conduct clinical trial 
Internal funds and Karnataka government award money 
 
Primary Sponsor  
Name  MicrobioTx Health Private Limited 
Address  363, 8th Main, 3rd Block, Koramangala, Bangalore, 560034 
Type of Sponsor  Other [Startup] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sonal Asthana  Aster CMI Hospital  Integrated Liver Care Unit, 5th floor 43/2, New Airport Road, NH-7, Sahakara Nagar, Hebbal, Bangalore, Karnataka-560092
Bangalore
KARNATAKA 		 9686976379

drsonal.asthana@asterhospital.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Aster CMI Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E638||Other specified nutritional deficiencies,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  59.00 Year(s)
Gender  Both 
Details  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). 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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)  		 The single time point at which the data will be analysed will be 26 weeks from the start of the study.  
 
Secondary Outcome  
Outcome  TimePoints 
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.
 
 
Target Sample Size   Total Sample Size="240"
Sample Size from India="240" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   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. 
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