Back to resultsTo Assess the Role of Fecal Microbiota Transplant in Acute Liver Failure
Primary Purpose
Acute Liver Failure
Status
Withdrawn
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Standard Medical Treatment
Fecal Microbiota Transplant
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acute Liver Failure
Eligibility Criteria
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
Sites / Locations
- Institute of Liver and Biliary Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Standard Medical Treatment+Fecal Microbiota Transplant
Standard Medical Treatment+Placebo
Arm Description
Outcomes
Primary Outcome Measures
Survival in both groups
Secondary Outcome Measures
Resolution of SIRS (Systemic Inflammatory Response Syndrome) in both groups
Reduction of ammonia in both groups
Improvement of Cerebral edema in both groups
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
Full Information
NCT ID
NCT03363022
First Posted
September 23, 2017
Last Updated
November 1, 2019
Sponsor
Institute of Liver and Biliary Sciences, India
1. Study Identification
Unique Protocol Identification Number
NCT03363022
Brief Title
To Assess the Role of Fecal Microbiota Transplant in Acute Liver Failure
Official Title
To Assess the Role of Fecal Microbiota Transplant in Acute Liver Failure- A Double Blind Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of Funds
Study Start Date
February 1, 2020 (Anticipated)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Liver Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Medical Treatment+Fecal Microbiota Transplant
Arm Type
Experimental
Arm Title
Standard Medical Treatment+Placebo
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Standard Medical Treatment
Intervention Description
Standard Medical Treatment includes antibiotics,CRRT (Continuous Renal replacement Therapy),Liver Dialysis.
Intervention Type
Other
Intervention Name(s)
Fecal Microbiota Transplant
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo will be identical and non medicinal to the Fecal Microbiota Transplant
Primary Outcome Measure Information:
Title
Survival in both groups
Time Frame
Day 21
Secondary Outcome Measure Information:
Title
Resolution of SIRS (Systemic Inflammatory Response Syndrome) in both groups
Time Frame
Day 1,2,5,7,14,21
Title
Reduction of ammonia in both groups
Time Frame
Day 1,2,5,7,14,21
Title
Improvement of Cerebral edema in both groups
Description
Improvement is defined as transcranial doppler < 0.9/Features suggestive of edema in CT imaging
Time Frame
Day 1,2,5,7,14,21
Title
Improvement in SOFA (Sequential Organ Failure Assessment) Score in both groups
Time Frame
Day 21
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Institute of Liver and Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
To Assess the Role of Fecal Microbiota Transplant in Acute Liver Failure
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