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

Institute of Liver and Biliary Sciences, India

Status: Withdrawn

Conditions: Acute Liver Failure

Treatments: Other: Placebo; Other: Fecal Microbiota Transplant; Drug: Standard Medical Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03363022

ILBS-ALF-04

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Standard Medical Treatment+Fecal Microbiota Transplant

Experimental group

Treatment:

Drug: Standard Medical Treatment

Other: Fecal Microbiota Transplant

Standard Medical Treatment+Placebo

Active Comparator group

Treatment:

Drug: Standard Medical Treatment

Other: Placebo