Health Condition 1: K746- Other and unspecified cirrhosis ofliver
Conditions
Interventions
Intervention1: Fecal Microbiota transplant and Standard Medical Treatment: FMT: Three doses (30ml one dose) of FMT will be given via jejunal port of NJ/NG tube once daily for 3 days.
SMT: Lactulose
Sponsors
Institute of Liver and Biliary Sciences
Eligibility
Inclusion criteria
Inclusion criteria: All cirrhotic patients between 18 years to 70 years, who have recovered within 7 days from hepatic encephalopathy after hospitalization
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients developing an episode of hepatic encephalopathy within 6 monthsTimepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactDr Shiv Kumar Sarin
Institute of Liver and Biliary Sciences
Outcome results
None listed