Research

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Research is going on around the world into the causes of and treatments for OC. This page describes some of the research that is being carried out by research groups in London and Salamanca.

If you want to look into the science for yourself, take a look at the list of research papers published on OC.

Research

What is known so far

Research into the causes of OC has been ongoing for over 30 years. However, researchers are still a long way from fully understanding the condition. Below is a brief summary of the key findings of OC research.

Genetic variation

It has been shown that in some women there is variation in some genes responsible for the transport of molecules in the liver. These molecules are involved in the formation of bile, and when there is variation they work less efficiently. This means that there is a build up of bile acids in the blood, resulting in the symptoms of OC. Although this has been a huge focus for research in OC we are still a long way from explaining all cases by means of genetic variation and the work continues today.

Bile acids

A blood bile acid level of over 40 micromol/L at any time during a pregnancy appears to be associated an increased risk of complications for your baby, including fetal distress and premature labour. It should be noted that the most recent large Swedish study measured fasting bile acid levels. In the UK, random blood samples are most commonly taken and the effect of food on bile acid level has not fully been established. More work is needed in this area to see if there is a similar correlation between random bile acid level and risk to the baby.

UDCA

There is some evidence that UDCA treatment not only relieves the symptoms experienced by the mother, but may also offer some protection against the harmful effects of bile acids for the baby. These findings need to be confirmed in studies with larger numbers of women, and the mechanism established.

Bile acids and fetal complications

There are several ways in which bile acids may harm your baby. These include abnormal heart rhythms, abnormal contraction of the veins supplying your baby with nutrients, increased sensitivity of the uterus to hormones which may trigger labour, increased sensitivity of the baby's intestines to bile acids, which may cause passage of meconium. Again, more research is needed in this area as some pregnancies seem to be at higher risk than others.

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Research groups

The London group

For the past 10 years, a team in London, based at Imperial College and led by Professor Catherine Williamson has been trying to understand the genetic causes of OC. Currently there are several projects continuing this aspect of the work, and also others trying to further understand the effects of bile acids on your baby’s heart.

London research group

Reproduced with kind permission of Action Medical Research

The London group is comprised of the people listed below. You can read about the work of Professor Catherine Williamson and Dr Saskia van Mil by clicking on their names.

Post-Doctoral Researchers

  • Dr Peter Dixon
  • Dr Shadi Abu-Hayyeh
  • Dr Georgia Papacleovoulou

PhD Students

  • Dominic Lawrance
  • Dr Marcus Martineau
  • Dr Erum Khan
Research Midwife

  • Suzan Jeffries
Research Assistant

  • Jenny Chambers
Congratulations to our former PhD students:
  • Victoria Geenes – will be returning to medical school to complete her final year
  • Alexandra Milona – will continue to work in the group for a while
  • Bryn Owen – will be taking up a new post in the USA
  • Hamimah Sheikh Abdul Khadir
Professor Catherine Williamson

Our group has studied different aspects of obstetric cholestasis over the past 10 years. We are particularly interested in why some women develop the condition. This is likely to be explained by genetic factors and also by the way the liver responds to raised levels of female hormones in pregnancy.

We have identified genetic variation in several genes that influence the way the liver controls bile acid levels. A small number of genetic abnormalities cause women to be very likely to develop OC when they are pregnant. However, in most cases there will not be just one genetic abnormality that makes them likely to develop the condition. Therefore we are also adopting more sophisticated approaches to the genetic analysis of the condition, and we are trying to identify groups of genes that can make pregnant women susceptible to cholestasis.

In addition to studying genetic causes of OC we are interested in how raised female hormones in pregnancy influence the liver and cause cholestasis. We are using several experimental models of cholestasis in pregnancy to study how oestrogen, progesterone and their metabolites influence the way the liver controls bile acid levels in the blood.

We are also studying the reasons that the babies of women with the disease can become unwell and, in severe cases, be stillborn. This part of the work includes studies of the placenta and also experiments to establish how bile acids may affect the heart of the unborn baby. We are studying how different drugs may prevent bile acid-induced damage to fetal tissues.

Work performed by several groups has shown that the drug ursodeoxycholic acid improves the symptoms and liver test abnormalities of women with OC. We are performing studies to try to understand whether this drug also improves the outlook for the baby. These include laboratory studies and a clinical trial. This trial is a collaborative study which is coordinated by Nottingham University and has several collaborating hospitals, including Queen Charlotte’s Hospital and St Mary’s Hospital from Imperial College London, St Thomas’ Hospital, Sunderland Hospital, Kings Mill, Mansfield and Heartlands/Good Hope Hospital, Birmingham.

We are currently starting a new project to establish whether the presence of cholestasis during pregnancy will influence the mother’s subsequent health or that of her children.

Our work has used a considerable number of samples from women who have had OC and their relatives. Several women have also given their time to raise funds for our work. We are very grateful to all the women who have helped us and hope that this work will improve the health of women with OC and their babies in the future.

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The Utrecht Group

By Dr Saskia van Mil

Bile homeostasis
Each day, approximately 500 mg of bile acids are synthesized from cholesterol in the adult human liver. Newly synthesized bile acids are conjugated with either glycine or taurine and subsequently secreted into bile and stored in the gallbladder. Biliary secretion of bile salts against a concentration gradient requires the hydrolysis of ATP and this process provides the driving force for bile flow. Because of detergent properties, bile acids are inherently cytotoxic, and hence it is important that intracellular levels of bile acids are tightly regulated. This is largely accomplished by transcriptional regulation of genes encoding proteins involved in bile acid synthesis and transport. Cholestasis, or impaired bile flow, is one of the most common and devastating manifestations of liver disease. Cholestasis is clinically characterized by elevated plasma concentrations of biliary constituents, resulting in jaundice, malabsorption of fats and fat-soluble vitamins and, in many cases, progressive liver damage. Both acquired and hereditary forms of cholestasis have been described.

About me
Saskia van MilI am a Dutch scientist who worked in Catherine Williamson’s group at Imperial College London. Over the course of my BSc project, PhD and post-doc position, I have cultivated a strong research interest in bile acid-related physiology, with particular reference to cholestasis. During my PhD programme in the University Medical Center in Utrecht, The Netherlands, I focussed on elucidating the genetic defect in two cholestatic disorders occurring in young childhood, BRIC and PFIC. I was involved in the study that demonstrated that mutations in FIC1, an aminophospholipid transporter, were causative for a subgroup of these patients. Following up from this study, we identified a second form of BRIC associated with mutations in the bile salt export pump (BSEP). Furthermore, I investigated the subcellular expression pattern of FIC1 in the liver. We revealed FIC1 localisation at apical membranes of cholangiocytes and hepatocytes and demonstrated that FIC1 is expressed in a tissue specific and developmentally-regulated fashion at the apical membranes of epithelial cells of the gastrointestinal tract. During my PhD project I became interested in the regulation of bile acid homeostasis by nuclear hormone receptors, and therefore approached Catherine Williamson to explore new ideas about the role of nuclear receptors and endocrine regulation of transporters in bile homeostasis.

Functional FXR variants associated with ICP
Because of the intrinsic toxicity of bile acids, bile acid synthesis and transport are tightly regulated. It has recently become apparent that members of the nuclear receptor family of transcription factors are key regulators of these physiological processes1. The transcription factor FXR (farnesoid X receptor) functions as a critical sensor of bile acid levels in the enterohepatic circulation and modulates bile homeostasis by binding to DNA response elements in promoter regions of target genes. Thus, FXR protects the body from the deleterious effect of bile acid overload by decreasing their endogenous synthesis and by accelerating bile acid biotransformation and excretion into bile, thereby preventing the occurrence of cholestasis. Synthetic FXR ligands may therefore represent a promising therapy for cholestasis. During my post-doc at Imperial College with Catherine Williamson, I hypothesised that FXR mutations cause ICP. Indeed, we identified four heterozygous variants in FXR in 92 women with ICP. Case-control studies of these variants in two independent cohorts of ICP patients and controls, demonstrated that three occur more commonly in ICP patients than controls. We subsequently demonstrated functional defects for three variants. This study showed for the first time that functional variants in FXR are associated with human disease and it provided pivotal pilot data for this proposal.

Role of reproductive hormones in ICP
Reproductive hormones also have important roles in the pathogenesis of ICP. The disease starts usually in the last trimester of pregnancy, when hormone concentrations are high, and resolves after delivery2, 3. Twin pregnancies display both a higher incidence of ICP and more pronounced rises in hormone levels. Additionally, ICP patients often present with cholestasis outside pregnancy when taking oral contraceptives. The molecular mechanisms through which reproductive hormones influence bile homeostasis are currently poorly understood. Further studies to elucidate the role of reproductive hormones in bile homeostasis will be essential to unravel the pathogenesis of ICP. Such studies will also have a general impact on our understanding of the molecular mechanisms of bile formation and may therefore improve clinical management of both hereditary and acquired forms of cholestasis.

In January 2007  I started my own group at the University Medical Center Utrecht, The Netherlands, investigating the role of reproductive hormones in bile homeostasis. We  collaborate with Catherine Williamson's group.

Reference list

1. Chiang JY. Bile acid regulation of gene expression: roles of nuclear hormone receptors. Endocr Rev 2002;23:443-463.

2. Kreek MJ. Female sex steroids and cholestasis. Semin Liver Dis 1987;7:8-23.

3. Reyes H, Sjovall J. Bile acids and progesterone metabolites in intrahepatic cholestasis of pregnancy. Ann Med 2000;32:94-106.

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The Salamanca group, Spain

By Jose Marín

For the last 10 years the Group of Research on Experimental Hepatology and Drug Targeting (HEVEFARM) at the University of Salamanca, Spain has been interested in the study of the causes and disease progression of obstetric cholestasis. Particular attention has been devoted to the investigation of the consequences of bile acid accumulation in the mother on 1) The liver of the developing foetus and 2) The structure and function of the placenta. The group is also interested in evaluating the effect of several drugs, such as ursodeoxycholic acid, on the foetus and placenta of these pregnancies. Salamanca research groupRecently, the group has directed studies toward the investigation of treating women with OC using antioxidant drugs and food to enhance the protection of the foetus and the placenta against the oxidative stress. Oxidative stress is caused by the over-production of reactive oxygen-related molecules; so called free-radicals which arecaused by the accumulation of bile acids in the maternal blood. Because of the great interest in investigating this disease, and in order to improve the available therapy to improve the condition of these pregnant women and reduce risk to the foetus, several collaborative studies are being conducted. These form part of a joint effort with research groups from several European countries, in particular with that of Dr. Catherine Williamson at Imperial College, in London.

More information on the research group, staff, activities, and a complete list of publications can be found at at the HEVEFARM Web site: (http://hepatitis.dep.usal.es/jjgmarin/HOME.html).

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How you can help

There are different ways in which you can help with the research, depending on how involved you feel that you would like to be. You do not have to be pregnant to take part in the study. Please do not feel obliged to take part, but if you would like to please contact Jenny Chambers (JennyChambersoc@aol.com).

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PITCH

PITCH (Pregnancy Intervention Trial in Cholestasis) is a research project to test the efficacy of UDCA, a drug often used to treat OC. It is a pilot study with the intention of moving on to a full-scale trial. The research is being conducted at various centres around the UK. Click here to find out more.

Donate

Donate!

There are various ways for you to support research into OC. Click here for more information.

Disclaimer

This site is intended to provide general information about obstetric cholestasis. It is not intended to, nor does it, constitute medical or other advice. For more details, click here.