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

Not Applicable

Withdrawn

• Conditions: Acute Liver Failure
• Interventions: Drug: Standard Medical Treatment; Other: Fecal Microbiota Transplant; Other: Placebo

• Registration Number: NCT03363022
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-23
• Study First Submitted QC: 2017-12-04
• Study First Posted: 2017-12-05
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-01
• Last Update Posted: 2019-11-05
• Study Start: 2020-02-01
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Medical Treatment+Fecal Microbiota Transplant	Standard Medical Treatment	-
Standard Medical Treatment+Fecal Microbiota Transplant	Fecal Microbiota Transplant	-
Standard Medical Treatment+Placebo	Standard Medical Treatment	-
Standard Medical Treatment+Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Survival in both groups	Day 21

Secondary Outcome Measures

Name	Time	Method
Reduction of ammonia in both groups	Day 1,2,5,7,14,21
Resolution of SIRS (Systemic Inflammatory Response Syndrome) 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 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	Day 21

Trial Locations

Locations (1)

Institute of Liver and Biliary Sciences; 🇮🇳 New Delhi, Delhi, India