A Comparison of Fecal Microbiota Transplantation and Steroid Therapy in Patients With Severe Alcoholic Hepatitis.
Status:
Unknown status
Trial end date:
2020-06-30
Target enrollment:
Participant gender:
Summary
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.