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

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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

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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
Actual Study Start Date : November 27, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

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




Primary Outcome Measures :
  1. Survival in both groups [ Time Frame: Day 21 ]

Secondary Outcome Measures :
  1. Resolution of SIRS (Systemic Inflammatory Response Syndrome) in both groups [ Time Frame: Day 1,2,5,7,14,21 ]
  2. Reduction of ammonia in both groups [ Time Frame: Day 1,2,5,7,14,21 ]
  3. 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

  4. Improvement in SOFA (Sequential Organ Failure Assessment) Score in both groups [ Time Frame: Day 21 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03363022


Contacts
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Contact: Dr Harsh Vardhan Tevethia, MD 01146300000 Hershey4686@gmail.com

Locations
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India
Institute of Liver and Biliary Sciences Not yet recruiting
New Delhi, Delhi, India, 110070
Institute of Liver and Biliary Sciences Recruiting
New Delhi, Delhi, India, 110070
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India

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Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT03363022     History of Changes
Other Study ID Numbers: ILBS-ALF-04
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: December 5, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Failure
Hepatic Insufficiency
Liver Failure, Acute
Liver Diseases
Digestive System Diseases