Status:
UNKNOWN
Efficacy and Safety of Fecal Microbiota Transplant for Secondary Prophylaxis of Hepatic Encephalopathy
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
Hepatic Encephalopathy
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Despite standard of care, the recurrence of hepatic encephalopathy remains the primary cause for readmissions in individuals with cirrhosis. Patients with cirrhosis have disturbed gut microbiota, whic...
Detailed Description
Hypothesis Engraftment of healthy donor microbiota in cirrhotic patients with hepatic encephalopathy curtails dysbiosis which subsequently prevent further episodes of hepatic encephalopathy and thereb...
Eligibility Criteria
Inclusion
- \- All cirrhotic patients between 18 years to 70 years, who have recovered within 7 days from hepatic encephalopathy after hospitalization
Exclusion
- Patient having hepatic encephalopathy after obvious precipitants (eg. diuretics, dehydration)
- Patients on immunosuppressive medications
- Active Infection (documented blood culture positive, Imaging diagnosis or SIRS\>=1)
- AKI (Defined as per KIDGO guidelines)
- GI Bleed (In past 14 days)
- Hepatocellular carcinoma
- Patient with portosystemic shunt with size \>10mm
- Patients with previous TIPS or shunt surgery
- Patients with significant comorbid illness such as heart, respiratory, or renal failure
- Any neurologic diseases such as Alzheimer's disease, Parkinson's disease
- Non hepatic metabolic encephalopathies
- Not willing for the study
Key Trial Info
Start Date :
January 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT05229289
Start Date
January 31 2022
End Date
December 31 2022
Last Update
February 8 2022
Active Locations (1)
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1
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India, 110070