An observational study in Cholestasis, Primary Sclerosing Cholangitis and Primary Biliary Cirrhosis, sponsored by Guy's and St Thomas' NHS Foundation Trust. Status unknown at 2 sites in United Kingdom. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-02.
Sponsored by Guy's and St Thomas' NHS Foundation Trust · Observational
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.
214 studies on the registry are indexed under Liver Cirrhosis, Biliary; 48 are open to participants now.
This study's planned enrollment of 200 is below the median of 380 across 54 observational studies indexed under Liver Cirrhosis, Biliary.
Browse Liver Cirrhosis, Biliary studies →Guy's and St Thomas' NHS Foundation Trust is the lead sponsor of 295 studies on the registry; 80 are open to participants now.
Compared within Liver Cirrhosis, Biliary, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Cholestasis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Men with cholestatic liver conditions including but not restricted to Primary Sclerosing Cholangitis and Primary Biliary Cholangitis.
Fathers with cholestatic liver conditions including but not restricted to Primary Sclerosing Cholangitis and Primary Biliary Cholangitis and their children aged 16 - 25 yeas of age.
Sperm Epigenome Arm:
Cholestatic men
Inclusion Criteria:
Exclusion Criteria:
Healthy men
Inclusion Criteria:
Exclusion Criteria:
Outcomes Arm:
Fathers
Inclusion Criteria:
Exclusion Criteria:
Children of cholestatic fathers
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Men with no significant health problems.
Other: Questionnaire, semen sample, fasting blood sample
Men with a cholestatic liver condition including but not restricted to Primary Sclerosing Cholangitis and Primary Biliary Cholangitis.
Other: Questionnaire, semen sample, fasting blood sample
Fathers who were diagnosed with a cholestatic liver condition including but not restricted to Primary Sclerosing Cholangitis and Primary Biliary Cholangitis either before or after the conception of their child who is now aged 16 - 25 years of age.
Other: Questionnaire
16 - 25 years-old children of fathers who were diagnosed with a cholestatic liver condition including but not restricted to Primary Sclerosing Cholangitis and Primary Biliary Cholangitis either before or after their conception.
Other: Questionnaire, fasting blood sample
Participants are asked to complete a questionnaire and provide a semen sample and fasting blood sample.
Participants are asked to complete a questionnaire.
Participants are asked to complete a questionnaire and provide a fasting blood sample.
Impact of male cholestasis on DNA methylation patterns in sperm
Time frame: 01/04/2018
Impact of male cholestasis on small RNA content in sperm
Time frame: 01/04/2018
Impact of male cholestasis on sperm histone retention
Time frame: 01/04/2018
Impact of paternal cholestasis on the BMI, hip and waist girth of their adolescent / young adult children
Time frame: 01/04/2018
Impact of paternal cholestasis on the general health of their adolescent / young adult children
The prevalence of heart, lung, diabetes, thyroid, kidney or liver disease in children of fathers with cholestasis will be investigated
Time frame: 01/04/2018
Impact of male cholestasis on seminal fluid composition.
Time frame: 01/04/2018
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Guy's and St Thomas' NHS Foundation Trust →