CholestasisPIP-CNCT03337074
Paternally Inherited Phenotypes in Cholestasis
An observational study of Cholestasis and Primary Sclerosing Cholangitis, run by Guy's and St Thomas' NHS Foundation Trust at 2 sites in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cholestasis, Primary Sclerosing Cholangitis, Primary Biliary Cirrhosis
- What is being tested?
- Questionnaire, semen sample, fasting blood sample, Questionnaire and Questionnaire, fasting blood sample
- How many people
- 200 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 8 Feb 2017to 30 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- Men who have a diagnosis of a cholestatic liver condition including but not restricted to Primary Sclerosing Cholangitis and Primary Biliary Cholangitis.
- Me who are able and willing to give informed consent.
- Men who have no history of cholestasis, liver disease, diabetes or obesity.
- Me who are able and willing to give informed consent.
- Fathers with a cholestatic liver condition including but not restricted to Primary Sclerosing Cholangitis and Primary Biliary Cholangitis.
- Fathers with cholestatic liver condition whose children are between 16 years - 25 years of age.
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- Fathers with cholestatic liver condition who are able and willing to give informed consent.
- Adolescents / young adults (between 16 - 25 years of age) whose fathers have a cholestatic liver condition including but not restricted to Primary Sclerosing Cholangitis or Primary Biliary Cholangitis.
- Adolescents /young adults born from an uncomplicated singleton pregnancy.
- Adolescents /young adults who are able and willing to give informed consent.
Who cannot join
- Men who have a history of diabetes or obesity.
- Men who have gallstones, cancer or other acute cholestatic pathology.
- Men who have a history of alcohol excess or drug abuse.
- Men who smoke.
- Men who have blood-borne viruses e.g. HIV or hepatitis.
- Men unable or unwilling to give informed consent
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- Healthy men
- Men who have a history of cholestasis or liver disease.
- Men who have a history of diabetes or obesity.
- Men who have a history of alcohol excess or drug abuse.
- Men who smoke.
- Men who have blood-borne viruses e.g. HIV or hepatitis.
- Men undergoing fertility treatment due to male factor.
- Men unable or unwilling to give informed consent
- Outcomes Arm:
- Fathers
- Fathers with a history of diabetes or obesity at the time of conception of their child.
- Fathers with a history of alcohol excess or drug-abuse at the time of conception of their child.
- Fathers who smoked at the time of conception of their child.
- Fathers with blood-borne viruses e.g. HIV and hepatitis at the time of conception of their child.
- Fathers unable or unwilling to give informed consent.
- Children of cholestatic fathers
- Adolescents / young adults who were born as a result of multi-fetal pregnancy.
- Adolescents / young adults with a history of alcohol excess or drug-abuse.
- Adolescents / young adults who are under 16 years of age, or over 25 years of age.
- Adolescents / young adults with blood-borne viruses e.g. HIV and hepatitis.
- Adolescents / young adults who are unable or unwilling to give informed consent.
Trial locations and contacts
2 sites in 1 country.
Catherine Williamson contact
United Kingdom2 sites, 2 recruiting
- Recruiting
Assisted Conception Unit, Guy's Hospital
London, SE1 9RT
Jean Bvumbe, Jean.Bvumbe@gstt.nhs.uk
- Recruiting
King's College Hospital
London, SE5 9RS
Bernadette Solis, 02032991495, bernadette.solis@nhs.net
About this study
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.
Read more
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.
- Being tested
- Questionnaire, semen sample, fasting blood sample, Questionnaire, Questionnaire, fasting blood sample
- Medical subject headings
- Cholestasis, Cholangitis, Sclerosing, Liver Cirrhosis, Biliary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire, semen sample, fasting blood sampleOther
Participants are asked to complete a questionnaire and provide a semen sample and fasting blood sample.
QuestionnaireOther
Participants are asked to complete a questionnaire.
Questionnaire, fasting blood sampleOther
Participants are asked to complete a questionnaire and provide a fasting blood sample.
| Study group | Role | What they receive |
|---|---|---|
| Sperm Epigenome arm/healthy men | Men with no significant health problems. Receives: Other: Questionnaire, semen sample, fasting blood sample | |
| Sperm Epigenome arm/cholestatic men | Men with a cholestatic liver condition including but not restricted to Primary Sclerosing Cholangitis and Primary Biliary Cholangitis. Receives: Other: Questionnaire, semen sample, fasting blood sample | |
| Outcomes arm/Cholestatic fathers | 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. Receives: Other: Questionnaire | |
| Outcomes arm/Children of cholestatic fathers | 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. Receives: Other: Questionnaire, fasting blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of male cholestasis on DNA methylation patterns in sperm
Measured: 01/04/2018
Impact of male cholestasis on small RNA content in sperm
Measured: 01/04/2018
Impact of male cholestasis on sperm histone retention
Measured: 01/04/2018
Impact of paternal cholestasis on the BMI, hip and waist girth of their adolescent / young adult children
Measured: 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
Measured: 01/04/2018
Secondary outcomes (1)
Impact of male cholestasis on seminal fluid composition.
Measured: 01/04/2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start8 Feb 2017
- Primary completion30 Apr 2020 (estimated)
- Study completion30 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholestasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College Hospital NHS Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03337074
- Sponsor's protocol ID
- 182833
- Acronym
- PIP-C
- Status last verified
- Jul 2019
- First submitted
- 1 Nov 2017
- Last updated
- 2 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03337074
- Acronym / sponsor ID
- PIP-C / 182833
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- King's College Hospital NHS Trust
- Study start
- 8 Feb 2017 (actual)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 30 Apr 2020 (estimated)
- First posted
- 8 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sperm Epigenome arm/healthy men | – | Other: Questionnaire, semen sample, fasting blood sampleMen with no significant health problems. |
| Sperm Epigenome arm/cholestatic men | – | Other: Questionnaire, semen sample, fasting blood sampleMen with a cholestatic liver condition including but not restricted to Primary Sclerosing Cholangitis and Primary Biliary Cholangitis. |
| Outcomes arm/Cholestatic fathers | – | Other: QuestionnaireFathers 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. |
| Outcomes arm/Children of cholestatic fathers | – | Other: Questionnaire, fasting blood sample16 - 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (10 listed)
- Men who have a diagnosis of a cholestatic liver condition including but not restricted to Primary Sclerosing Cholangitis and Primary Biliary Cholangitis.
- Me who are able and willing to give informed consent.
- Men who have no history of cholestasis, liver disease, diabetes or obesity.
- Me who are able and willing to give informed consent.
- Fathers with a cholestatic liver condition including but not restricted to Primary Sclerosing Cholangitis and Primary Biliary Cholangitis.
Key exclusion criteria (27 listed)
- Men who have a history of diabetes or obesity.
- Men who have gallstones, cancer or other acute cholestatic pathology.
- Men who have a history of alcohol excess or drug abuse.
- Men who smoke.
- Men who have blood-borne viruses e.g. HIV or hepatitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire, semen sample, fasting blood sampleParticipants are asked to complete a questionnaire and provide a semen sample and fasting blood sample. | Other | Sperm Epigenome arm/cholestatic men, Sperm Epigenome arm/healthy men |
| QuestionnaireParticipants are asked to complete a questionnaire. | Other | Outcomes arm/Cholestatic fathers |
| Questionnaire, fasting blood sampleParticipants are asked to complete a questionnaire and provide a fasting blood sample. | Other | Outcomes arm/Children of cholestatic fathers |
Primary outcome
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
Time frame: 01/04/2018
The prevalence of heart, lung, diabetes, thyroid, kidney or liver disease in children of fathers with cholestasis will be investigated
1 secondary outcome
Impact of male cholestasis on seminal fluid composition.
Time frame: 01/04/2018
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Williamson contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholestasis and Primary Sclerosing Cholangitis, run by Guy's and St Thomas' NHS Foundation Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Saraid McIlvride (02078486202, saraid.a.mcilvride@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of male cholestasis on DNA methylation patterns in sperm (time frame: 01/04/2018). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2019; AzTrials last refreshed its copy on 29 Oct 2026.