Health Condition 1: K701- Alcoholic hepatitis
Conditions
Interventions
Intervention1: Fecal transplantation: 1. Donors will be supplied clean, sealable containers for collection and transport of stool. Containers will be labeled with the name, UHID and date/time of stool
Sponsors
Institute of Liver and Biliary Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Steroid ineligible severe alcoholic hepatitis as per definition 2. Informed consent 3. Age 18 - 70 years 4. Liver biopsy ââ?¬â??if Feasible 5. Model for End-Stage Liver Disease (MELD) ââ?°Â¥ 20 and Maddrey DF ââ?°Â¥ 32 Donor evaluation The subjects will be screened for 1. Routine laboratory tests (CBC; LFT; KFT; PT; INR) 2. Fasting blood sugar 3. Lipid profile 4. HBsAg 5. Anti-HCV 6. HIV 1 & 2 7. VDRL 8. Stool routine and microscopy stool ova & cysts. 9. Stool culture 10. Clostridium difficile toxin 11. Helicobacter pylori stool antigen 12. Cryptosporidium & Isospora (acid fast stain)
Exclusion criteria
Exclusion criteria: 1. UGI Bleed within last one month 2. More then 3 organ failure requiring support 3. Mechanically ventilated patient , (patients requiring ICU/ HDU care) (On inotropic support) 4. Uncontrolled sepsis, DIC 5. Gut paralysis 6. Active hepatic or extra hepatic malignancy 7. Renal failure creatinine > 2.5 8. DF >120 9. MELD >35 10. Prior SBP/active SBP 11. Intestinal conditions like IBD, SIBO Exclusion criteria for Donor 1. Antibiotic usage within 3 months of enrollment 2. Gastroenteritis within last 2 months 3. Obesity 4. Diabetes mellitus 5. Inflammatory bowel disease 6. Any Malignancy 7. Chronic Kidney disease, Coronary artery disease 8. Cerebrovascular accident or chronic obstructive pulmonary disease 9. HBsAg, Anti HCV, HIV seropositivity 10. Transaminitis, dyslipidemia 11. Ova or cyst in stool, C. difficile toxin Positive 12. Chronic alcohol intake 13. Active substance abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Mortality at 3 month. 2) Liver transplant free survival at 3 month. Timepoint: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| End of study periodTimepoint: 6 months;Frequency of decompensation events on follow up periodTimepoint: 6 months;MortalityTimepoint: 1 month;Post therapy assessment in the form of clinical improvement (hepatic encephalopathy, ascites , improvement in jaundice)(both ascites and HE if present)Timepoint: 6 months | — |
Countries
India
Contacts
Public ContactDr Shasthry S M
Institute of Liver and Biliary Sciences
Outcome results
None listed