Primary Sclerosing Cholangitis Clinical Trial
Official title:
Investigation of the Effect of Raised Serum Bile Acids on the Epigenome of Sperm and the Association With the Metabolic Health of the Children of Men With Cholestasis: a Case-control Study.
For some years investigators have known that the health of fathers at the time their baby is
conceived has an influence on the health of their child in the future. Many studies looking
at this effect have investigated fathers with obesity and other metabolic disorders. These
disorders can alter the risk of obesity and diabetes in the children of these men. More
recently, studies have been undertaken to establish the mechanism by which this risk is
inherited by the children. Studies of sperm have identified that changes in the structure and
function of the sperm play a role.
Primary Sclerosing Cholangitis (PSC) and Primary Biliary Cholangitis (PBC) are included in a
group of cholestatic liver disorders that are associated with elevated levels of bile acids
in the blood (cholestasis). A previous study has established that children born to women who
have cholestasis during pregnancy are at an increased risk of obesity later in life. Our
study will investigate whether there is a similar effect on the health of children if their
father has cholestasis.
The study has 2 arms, the Sperm Epigenome arm and the Outcomes arm.
In the Sperm Epigenome arm of the study, the structure and function of sperm from men with
PSC, PBC and other cholestatic liver disorders will be investigated and compared to the
structure and function of sperm from healthy men.
In the Outcomes arm of the study, basic health parameters of fathers who had PSC, PBC or
another cholestatic liver disease either before or after their child was conceived will be
studied. Basic health parameters will also be studied in their child when the child is
between 16 and 25 years of age.
n/a
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