Non-Alcoholic Fatty Liver Disease Clinical Trial
Official title:
Study of the Effect of Probiotics on the Clinical Outcomes and Gut Microenvironment in Patients With Non-alcoholic Fatty Liver Disease: a Randomised Controlled Trial
Fatty liver has been associated with high risk of progression to inflammation of the liver,
liver cirrhosis (hardening of the liver), and eventually can lead to liver cancer. So far,
the treatment for this condition involves controlling the cholesterol level in the body by
practicing low fat diet and daily exercise. However, recently there has been evidence that
alteration of the normal population of various types of bacteria that lives in the intestines
may contributes to the development of fatty liver.
Probiotics is a dietary supplement containing live bacteria that is formulated to change the
composition and population of the bacteria in the intestines. It is postulated that by taking
specifically formulated probiotics, the alteration of the intestinal bacteria may lead to
improvement of the fatty liver, leading to better daily liver function.
In this 6-month study, investigators would like to investigate the effectiveness of the
probiotics in improving the liver function and in the treatment of the fatty liver. It will
compare the fatty liver of patients who took the probiotics supplements compared to those who
did not took it and see if there is any improvement.
Non-alcoholic fatty liver disease (NAFLD) is one of the common causes of chronic liver
disease nowadays. NAFLD is considered as the hepatic manifestation of metabolic syndrome. In
Malaysia, the prevalence of metabolic disorders such as diabetes mellitus, obesity and
dyslipidemia are increasing with time. Despite the disease burden, treatments for NAFLD are
currently limited due to the ongoing evolving theory of its pathogenesis.
One of the proposed mechanisms is via gut-liver axis (GLA), whereby the role of gut
microbiota has been implicated. Two main components of GLA are gut microbiota and gut
barrier. A change in gut microbiota composition will predispose to gut barrier dysfunction,
which subsequently leads to bacterial by-products translocation into the portal circulation.
Eventually, these by-products reach the liver and trigger the cascades of hepatic
inflammation, leading to fatty liver and its disease progression.
The aim of this study is to investigate the role of probiotics in modulating the gut
microenvironment - namely gut microbiota composition, gut barrier function and local gut
inflammation, as well as its effect on the clinical outcomes in NAFLD patients.
Investigators propose a randomised, double-blind, placebo-controlled trial of 6-month
duration. Investigators aim to recruit 48 NALFD patients, with either treated with probiotics
or placebo. Small intestinal microbiota will be determined by 16S-rRNA sequencing and
immunoreactivity of zona occludens-1 (tight junction protein in the gut barrier) and
cytokines mRNA level will be measured. The degree of liver steatosis and stiffness will be
assessed by using transient elastography and biochemical blood tests. All these variables
will be determined pre- and post-intervention with probiotics/placebo.
This study will provide a valuable knowledge on the role of probiotics as the gut
microenvironment modulator and strengthen the hypothesis of GLA involvement in the NAFLD
development. Hence, probiotics can be strongly considered as one of the treatment options for
non-alcoholic fatty liver disease.
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