Fecal Transplant in alcoholic liver disease
- Conditions
- Health Condition 1: K701- Alcoholic hepatitis
- Registration Number
- CTRI/2022/03/041307
- Lead Sponsor
- Institute of Liver and Biliary Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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) � 20 and Maddrey DF � 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)
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Mortality at 3 month. <br/ ><br>2) Liver transplant free survival at 3 month. <br/ ><br> <br/ ><br>Timepoint: 3 months
- Secondary Outcome Measures
Name Time Method 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