To Assess the Role of Fecal Microbiota Transplant in Acute Liver Failure

Study Overview
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Brief Summary
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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.

Official Title
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To Assess the Role of Fecal Microbiota Transplant in Acute Liver Failure- A Double Blind Controlled Trial

Conditions
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Acute Liver Failure

Intervention / Treatment
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* Drug: Standard Medical Treatment
* Other: Fecal Microbiota Transplant
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute liver failure -Not meeting KCH Criteria/Meeting KCH Criteria but not having Liver transplant option Exclusion Criteria: Culture Positive Sepsis History of taking lactulose, rifaximin, neomycin, metronidazole, L-Ornithine L-Aspartate Receiving psychoactive drugs, promotility and hypomotility drugs Pregnant females

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard Medical Treatment+Fecal Microbiota Transplant<br> | Drug: Standard Medical Treatment<br>* Standard Medical Treatment includes antibiotics,CRRT (Continuous Renal replacement Therapy),Liver Dialysis.<br>Other: Fecal Microbiota Transplant<br>* 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.<br>|
| Active Comparator: Standard Medical Treatment+Placebo<br> | Drug: Standard Medical Treatment<br>* Standard Medical Treatment includes antibiotics,CRRT (Continuous Renal replacement Therapy),Liver Dialysis.<br>Other: Placebo<br>* Placebo will be identical and non medicinal to the Fecal Microbiota Transplant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival in both groups |  | Day 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Improvement is defined as transcranial doppler < 0.9/Features suggestive of edema in CT imaging | Day 1,2,5,7,14,21 | 
| Improvement in SOFA (Sequential Organ Failure Assessment) Score in both groups |  | Day 21 |