Stool therapy for improvement in liver disease
- Conditions
- Health Condition 1: K746- Other and unspecified cirrhosis ofliver
- Registration Number
- CTRI/2022/01/039314
- Lead Sponsor
- Institute of Liver and Biliary Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
All cirrhotic patients between 18 years to 70 years, who have recovered within 7 days from hepatic encephalopathy after hospitalization
1.Patient having hepatic encephalopathy after obvious precipitants
2.Patients on immunosuppressive medications
3.Active Infection (documented blood culture positive, Imaging diagnosis or SIRS more than equals to 1)
4.AKI (Defined as per KIDGO guidelines)
5.GI Bleed (In past 14 days)
6.Hepatocellular carcinoma
7.Patient with portosystemic shunt with size more than 10mm
8.Patients with previous TIPS or shunt surgery
9.Patients with significant comorbid illness such as heart, respiratory, or renal failure
10.Any neurologic diseases such as Alzheimer disease, Parkinson disease
11.Non hepatic metabolic encephalopathies
12.Not willing for the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients developing an episode of hepatic encephalopathy within 6 monthsTimepoint: 6 months
- Secondary Outcome Measures
Name Time Method Change in Ammonia level and Psychometric test/CFF pre and post FMTTimepoint: Day 28,90,180;Change in CTP and MELD scoreTimepoint: Day 28,90,180;Change in inflammatory markers pre and post FMTTimepoint: Day 28,90,180;Change in Stool microbiome and metabolomics and urinary metabolomics pre and post FMTTimepoint: Day 28,90,180;Proportion of patients developing adverse event related to FMT within 6 monthsTimepoint: 6 months;Transplant free survivalTimepoint: Day 28,90 and 180 days