A Comparison of Fecal Microbiota Transplantation and Steroid Therapy in Patients With Severe Alcoholic Hepatitis.

Study Overview
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Brief Summary
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Study population: Patients attending the Out Patient Department and admitted to Institute of Liver and Biliary Sciences. Study design: Prospective randomized controlled trial Study period: One year- January 2017- December 2018 Sample size: 130 (65 cases in each group) Intervention: The subjects will be given Fecal Microbiota Transplantation through a NJ tube placed after admission to the hospital. Participants will be administered the processed fecal microbiota sample collected from a related or unrelated healthy donor for a period of 7 days. Monitoring and assessment: The recipient will be monitored every day after Fecal Microbiota Transplantation therapy. The recipient will undergo physical examination, complete blood counts, at baseline and a chest X ray, serum procalcitonin, CRP and Tumor Necrosis Factor alpha levels, Liver Function Tests, Kidney Function Tests, International Normalized Ratio and arterial ammonia, at day 0,4,7,14,28,90,180,270 and 365 from the start of therapy. Microbiota analysis of the donors will be done at baseline and the recipients will be done on day 0,7,28,90 & 180.

Official Title
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A Comparison of Fecal Microbiota Transplantation and Steroid Therapy in Patients With Severe Alcoholic Hepatitis A Randomized Controlled Trial.

Conditions
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Severe Alcoholic Hepatitis

Intervention / Treatment
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* Other: Fecal Microbiota Transplantation
* Drug: Steroids


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with severe alcoholic hepatitis . Eligible for steroid therapy. Exclusion Criteria: Upper gastrointestinal bleed within the past one month. Active sepsis Serum creatinine > 1.5 mg/dl (Hepato renal syndrome) Intestinal paralysis Hepatic or extrahepatic malignancy Disseminated intravascular coagulation Discriminant Function (DF) >90

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fecal Microbiota Transplantation<br> | Other: Fecal Microbiota Transplantation<br>* Fecal Microbiota Transplantation will be given 100mL of suspension. It will given for a period of 7 days<br>|
| Active Comparator: Steroid<br> | Drug: Steroids<br>* Oral steroids 40 mg (prednisolone) will be given for a period of 7 days in hospital followed by 3 weeks on OPD basis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with Overall Survival at 3 months |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Child Pugh Turcotte (score) severity in both groups |  | 6 months | 
| Improvement in Model for End Stage Liver Disease (MELD) of liver disease severity in both groups |  | 6 months | 
| Improvement in Glasgow Alcoholic Hepatitis (score) in both groups |  | 6 months | 
| Improvement in Maddrey's Discriminant Function (score) in both groups |  | 6 months | 
| Adverse events in both groups |  | 6 months |