Severe Alcoholic Hepatitis Clinical Trial
Official title:
Fecal Microbiota Transplantation in Severe Alcoholic Hepatitis- Assessment of Impact on Prognosis and Short-term Outcome
Alcoholic liver disease has become one of the foremost causes of chronic liver disease across
the world, and a cause of considerable morbidity and mortality. Alcoholic steatohepatitis is
an entity in this broad spectrum, with severe alcoholic hepatitis transitioning to acute on
chronic liver failure carrying a one month mortality of as high as 20 to 50%.
The current management guidelines for severe alcoholic hepatitis show benefit with prolonged
alcohol abstinence, nutritional support, the use of corticosteroids, pentoxifylline or
N-acetyl cysteine (NAC) and early liver transplantation. However, major studies and
meta-analyses have demonstrated that these interventions, with the exception of early liver
transplantation, do not improve mortality rates to the level of statistical significance.
Owing to the high short term mortality associated with severe alcoholic hepatitis, the
inadequacy of a treatment that could significantly impact this short term mortality, and the
limited applicability of early liver transplantation, a study on newer modalities of
treatment is warranted.
The role that human gut microbiota plays in health and disease is receiving considerable
attention. Targeting intestinal dysbiosis, a phenomenon found to be intricately linked with
the causation of alcoholic hepatitis, could provide insights into novel therapeutic
strategies.
Fecal microbiota transplantation is a novel approach that has gained widespread acceptance in
in the management of recurrent severe Clostridium difficile infection. It's role is also
being studied in other diseases where an association with gut dysbiosis has been found, such
as in inflammatory bowel disease and irritable bowel syndrome. The role of FMT has also been
studied in liver diseases such as non-alcoholic fatty liver disease (NAFLD), liver cirrhosis
and primary sclerosing cholangitis. In this process, a diseased recipient is transferred
fecal material containing the microflora of a healthy individual. It limits the colonization
of pathogens, inducing colonization resistance, affects microbiota composition in the gut, as
well as metabolism in the microbial pathogens. FMT helps alleviate gut dysbiosis and restores
gut microbial diversity.
Our aim is to evaluate the role of FMT on short term survival and improvement in scores of
prognostic significance (CTP, MELD, MELDNa, mDF) in patients with severe alcoholic hepatitis.
n/a
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