Fecal Microbiota Therapy in Steroid Ineligible Alcoholic Hepatitis

• Status: Not yet recruiting
• Trial end date: 2024-03-31
• Target enrollment: 0
• Participant gender: All

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 show a limited utility in improving the short-term survival and boast no evidence of any long-term benefits. Additionally, only a small proportion of patients with alcoholic hepatitis are eligible to receive steroids. Thus, a large number of patients are either not eligible or do not respond to steroids and this group outnumbers those who do respond to steroids, leaving us without any specific therapeutic options for a majority of these individuals.Even liver transplantation is not feasible in most cases due to the presence of sepsis or recent alcohol consumption and many ethical and logistic issues are involved despite the documented safety and survival benefits of early liver transplantation in patients with severe alcoholic hepatitis (SAH) not responding to medical management.Therefore, newer, more effective, and nontransplant therapeutic options for managing severe alcoholic hepatitis are needed. Since gut dysbiosis, leaky gut, and products of the gut microbiome reaching the liver are the main culprits in the development of alcoholic hepatitis, targeting qualitative and quantitative changes in the gut microbiome remains an important strategy in developing new therapies for alcoholic hepatitis. Among others, the modulation of gut microbiota by fecal microbiota transplantation (FMT) has recently been conceptualized and evaluated as a potential therapeutic strategy in both preclinical and clinical studies.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Liver and Biliary Sciences, India

Criteria

Inclusion Criteria:

1. Steroid ineligible severe alcoholic hepatitis as per definition

2. Informed consent

3. Age 18 - 70 years

4. Liver biopsy -if Feasible

5. Model for End-Stage Liver Disease (MELD) ≥ 20 and Maddrey DF ≥ 32

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

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 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