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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
112
Fecal Microbiota Transplantation will be given 100mL of suspension. It will given for a period of 7 days
Oral steroids 40 mg (prednisolone) will be given for a period of 7 days in hospital followed by 3 weeks on OPD basis
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
Proportion of participants with Overall Survival at 3 months
Time frame: 3 months
Improvement in Child Pugh Turcotte (score) severity in both groups
Time frame: 6 months
Improvement in Model for End Stage Liver Disease (MELD) of liver disease severity in both groups
Time frame: 6 months
Improvement in Glasgow Alcoholic Hepatitis (score) in both groups
Time frame: 6 months
Improvement in Maddrey's Discriminant Function (score) in both groups
Time frame: 6 months
Adverse events in both groups
Time frame: 6 months
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