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

Acute Liver Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03363022
• Other study ID #: ILBS-ALF-04
• Status: Withdrawn
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: November 2019
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Liver Failure
• Hepatic Insufficiency
• Liver Failure
• Liver Failure, Acute

Intervention

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

Locations

Country	Name	City	State
India	Institute of Liver and Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival in both groups		Day 21
Secondary	Resolution of SIRS (Systemic Inflammatory Response Syndrome) in both groups		Day 1,2,5,7,14,21
Secondary	Reduction of ammonia in both groups		Day 1,2,5,7,14,21
Secondary	Improvement of Cerebral edema in both groups	Improvement is defined as transcranial doppler < 0.9/Features suggestive of edema in CT imaging	Day 1,2,5,7,14,21
Secondary	Improvement in SOFA (Sequential Organ Failure Assessment) Score in both groups		Day 21