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

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

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 Overview

• Status: Withdrawn
• Conditions: Acute Liver Failure
• Intervention / Treatment: Drug: Standard Medical Treatment; Other: Fecal Microbiota Transplant; Other: Placebo

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Institute of liver and Biliary Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2020
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: September 23, 2017
• First Submitted That Met QC Criteria: December 4, 2017
• First Posted (Actual): December 5, 2017

Study Record Updates

• Last Update Posted (Actual): November 5, 2019
• Last Update Submitted That Met QC Criteria: November 1, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Liver Failure; Hepatic Insufficiency; Liver Failure, Acute
• Other Study ID Numbers: ILBS-ALF-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No