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

Institute of Liver and Biliary Sciences, India

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Acute Liver Failure

Interventions

Standard Medical TreatmentDRUG

Standard Medical Treatment includes antibiotics,CRRT (Continuous Renal replacement Therapy),Liver Dialysis.

Fecal Microbiota TransplantOTHER

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.

PlaceboOTHER

Placebo will be identical and non medicinal to the Fecal Microbiota Transplant

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Outcomes

Primary Outcomes

Survival in both groups

Time frame: Day 21

Secondary Outcomes

Resolution of SIRS (Systemic Inflammatory Response Syndrome) in both groups

Time frame: Day 1,2,5,7,14,21

Reduction of ammonia in both groups

Time frame: 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

Time frame: Day 1,2,5,7,14,21

Improvement in SOFA (Sequential Organ Failure Assessment) Score in both groups

Time frame: Day 21

Data from ClinicalTrials.gov

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