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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Liver Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Standard Medical Treatment+Fecal Microbiota Transplant

Group Type EXPERIMENTAL

Standard Medical Treatment

Intervention Type DRUG

Standard Medical Treatment includes antibiotics,CRRT (Continuous Renal replacement Therapy),Liver Dialysis.

Fecal Microbiota Transplant

Intervention Type OTHER

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.

Standard Medical Treatment+Placebo

Group Type ACTIVE_COMPARATOR

Standard Medical Treatment

Intervention Type DRUG

Standard Medical Treatment includes antibiotics,CRRT (Continuous Renal replacement Therapy),Liver Dialysis.

Placebo

Intervention Type OTHER

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

Interventions

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Standard Medical Treatment

Standard Medical Treatment includes antibiotics,CRRT (Continuous Renal replacement Therapy),Liver Dialysis.

Intervention Type DRUG

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.

Intervention Type OTHER

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No