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

NCT03363022 | Withdrawn

• 1 other identifier: ILBS-ALF-04
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Liver Failure

Outcome Measures

Primary Outcomes (1)

• Survival in both groups

  Day 21

Secondary Outcomes (4)

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

  Day 21

Study Arms (2)

Standard Medical Treatment+Fecal Microbiota Transplant

EXPERIMENTAL

Drug: Standard Medical Treatment; Other: Fecal Microbiota Transplant

Standard Medical Treatment+Placebo

ACTIVE COMPARATOR

Drug: Standard Medical Treatment; Other: Placebo

Interventions

Standard Medical Treatment DRUG

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

Standard Medical Treatment+Fecal Microbiota Transplant; Standard Medical Treatment+Placebo

Fecal Microbiota Transplant OTHER

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.

Standard Medical Treatment+Fecal Microbiota Transplant

Placebo OTHER

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

Standard Medical Treatment+Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute liver failure -Not meeting KCH Criteria/Meeting KCH Criteria but not having Liver transplant option

You may not qualify if:

• Culture Positive Sepsis
• History of taking lactulose, rifaximin, neomycin, metronidazole, L-Ornithine L-Aspartate
• Receiving psychoactive drugs, promotility and hypomotility drugs
• Pregnant females

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Conditions

Liver Failure, Acute

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2017
• First Posted: December 5, 2017
• Study Start: February 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: November 5, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)