Acute Liver Failure
Conditions
Brief summary
All patients of Acute liver failure not meeting the KCH (King's College Hospital) criteria/or meeting KCH criteria not having option of liver transplant will be recruited for the trial. The first group will receive Standard medical care with Fecal Microbiota transplant on Day 1 for 3 consecutive days. FMT (Fecal Microbiota Transplant) will be delivered rectally which will be placed bedside. Suitable donor will be screened and the stool samples will be used as per criteria. Stool samples will be taken at the time at Day 0, 1(Post FMT), Day 4, 6, 14,21. Sepsis screen will be sent. Inflammatory markers will be sent on Day 0,1, 4,6, 14,21. The second group will receive standard medical therapy/and an placebo. Stool samples will be sent on Day 0,1, 4, 6 , 14,21. Inflammatory markers will be sent on the time on day 0,1 4,6 , 14,21.
Interventions
DRUGStandard Medical Treatment
Standard Medical Treatment includes antibiotics,CRRT (Continuous Renal replacement Therapy),Liver Dialysis.
OTHERFecal Microbiota Transplant
Fecal Microbiota Transplant Stool specimen (preferably Bristol Stool Type 3 or 4) with a weight of ∼50 g will be considered adequate. 250 mL sterile normal saline will be added to the stool sample and homogenized with a blender for 2-4minutes in pulses of 30 seconds with 10 seconds wait in between each pulse. Enema to be held for 30 minutes.
OTHERPlacebo
Placebo will be identical and non medicinal to the Fecal Microbiota Transplant
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Acute liver failure -Not meeting KCH Criteria/Meeting KCH Criteria but not having Liver transplant option
Exclusion criteria
1. Culture Positive Sepsis 2. History of taking lactulose, rifaximin, neomycin, metronidazole, L-Ornithine L-Aspartate 3. Receiving psychoactive drugs, promotility and hypomotility drugs 4. Pregnant females
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival in both groups | Day 21 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resolution of SIRS (Systemic Inflammatory Response Syndrome) in both groups | Day 1,2,5,7,14,21 | — |
| Reduction of ammonia in both groups | Day 1,2,5,7,14,21 | — |
| Improvement of Cerebral edema in both groups | Day 1,2,5,7,14,21 | Improvement is defined as transcranial doppler \< 0.9/Features suggestive of edema in CT imaging |
| Improvement in SOFA (Sequential Organ Failure Assessment) Score in both groups | Day 21 | — |
Countries
India
Outcome results
None listed