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

Sponsor

Institute of Liver and Biliary Sciences, India (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03363022

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Liver Failure	Drug: Standard Medical Treatment Other: Fecal Microbiota Transplant Other: Placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2020

Anticipated Primary Completion Date :

Dec 31, 2020

Anticipated Study Completion Date :

Dec 31, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Survival in both groups [Day 21]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Liver and Biliary Sciences	New Delhi	Delhi	India	110070

Sponsors and Collaborators

Institute of Liver and Biliary Sciences, India

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Institute of Liver and Biliary Sciences, India

ClinicalTrials.gov Identifier:

NCT03363022

Other Study ID Numbers:

ILBS-ALF-04

First Posted:

Dec 5, 2017

Last Update Posted:

Nov 5, 2019

Last Verified:

Nov 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Liver Failure

Hepatic Insufficiency

Liver Failure, Acute

Study Results

No Results Posted as of Nov 5, 2019