Fecal Microbiota Therapy in Steroid Ineligible Alcoholic Hepatitis
Alcoholic Hepatitis
About this trial
This is an interventional treatment trial for Alcoholic Hepatitis
Eligibility Criteria
Inclusion Criteria:
- Steroid ineligible severe alcoholic hepatitis as per definition
- Informed consent
- Age 18 - 70 years
- Liver biopsy -if Feasible
- Model for End-Stage Liver Disease (MELD) ≥ 20 and Maddrey DF ≥ 32
Exclusion Criteria:
- UGI Bleed within last one month
- More then 3 organ failure requiring support
- Mechanically ventilated patient , (patients requiring ICU/ HDU care) (On inotropic support)
- Uncontrolled sepsis, DIC
- Gut paralysis
- Active hepatic or extra hepatic malignancy
- Renal failure creatinine > 2.5
- DF>120
- MELD >35
- Prior SBP/active SBP
- Intestinal conditions like IBD, SIBO
Donor evaluation The subjects will be screened for
- Routine laboratory tests (CBC; LFT; KFT; PT; INR)
- Fasting blood sugar
- Lipid profile
- HBsAg
- Anti-HCV
- HIV 1 & 2
- VDRL
- Stool routine and microscopy stool ova & cysts.
- Stool culture
- Clostridium difficile toxin
- Helicobacter pylori stool antigen
- Cryptosporidium & Isospora (acid fast stain) 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
Sites / Locations
- Institute of Liver & Biliary SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Fecal Transplantation
Standard Medical Treatment
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 collection. Collected stool will be immediately transferred to the laboratory facility for processing and used within 6 hours collection Stool sample from Healthy donor will be processed Patient preparation Patient was kept NPO for 4 hours prior to stool instillation Iv antibiotics were continued as per treating doctor in the event of sepsis The patient was allowed to consume the prescribed diet 2 hours after the procedure instillation Methods of FMT infusion. Seven doses (30gm one dose) of FMT will be given via jejunal port of NJ/NG tube
Standard Medical Treatment