Status:
UNKNOWN
Fecal Microbiota Therapy in Steroid Ineligible Alcoholic Hepatitis
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
Alcoholic Hepatitis
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Alcoholic hepatitis, the most florid form of alcoholic liver disease, has a very high short-term mortality of up to 50% and no specific therapies are available other than steroids. Steroids also only ...
Detailed Description
AIM- To assess survival benefit at 3 month, in patients of severe alcoholic hepatitis who are steroid ineligible. Methodology: Study population: Fecal microbiota therapy in steroid ineligible Alcoho...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2024
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT05285592
Start Date
April 1 2022
End Date
March 31 2024
Last Update
April 20 2022
Active Locations (1)
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1
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India, 110070