Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03363022
Recruitment Status : Unknown
Verified July 2017 by Institute of Liver and Biliary Sciences, India.
Recruitment status was:  Recruiting
First Posted : December 5, 2017
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India

Tracking Information
First Submitted Date  ICMJE September 23, 2017
First Posted Date  ICMJE December 5, 2017
Last Update Posted Date December 5, 2017
Actual Study Start Date  ICMJE November 27, 2017
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2017)
Survival in both groups [ Time Frame: Day 21 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2017)
  • Resolution of SIRS (Systemic Inflammatory Response Syndrome) in both groups [ Time Frame: Day 1,2,5,7,14,21 ]
  • Reduction of ammonia in both groups [ Time Frame: Day 1,2,5,7,14,21 ]
  • Improvement of Cerebral edema in both groups [ Time Frame: 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 [ Time Frame: Day 21 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE To Assess the Role of Fecal Microbiota Transplant in Acute Liver Failure
Official Title  ICMJE To Assess the Role of Fecal Microbiota Transplant in Acute Liver Failure- A Double Blind Controlled Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acute Liver Failure
Intervention  ICMJE
  • 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.

  • Other: Placebo
    Placebo will be identical and non medicinal to the Fecal Microbiota Transplant
Study Arms  ICMJE
  • Experimental: Standard Medical Treatment+Fecal Microbiota Transplant
    Interventions:
    • Drug: Standard Medical Treatment
    • Other: Fecal Microbiota Transplant
  • Active Comparator: Standard Medical Treatment+Placebo
    Interventions:
    • Drug: Standard Medical Treatment
    • Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 4, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2018
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03363022
Other Study ID Numbers  ICMJE ILBS-ALF-04
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Institute of Liver and Biliary Sciences, India
Study Sponsor  ICMJE Institute of Liver and Biliary Sciences, India
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Institute of Liver and Biliary Sciences, India
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP