Il-17 Levels in Intrahepatic Cholestasis of Pregnancy

Brief Title

Il-17 Levels in Intrahepatic Cholestasis of Pregnancy

Official Title

to Investigate the Maternal Serum IL-17 Levels in Pregnant Women With Intrahepatic Cholestasis of Pregnancy

Brief Summary

      The aim of this study is to investigate maternal and fetal serum IL-17 levels in pregnant
      women with intrahepatic cholestasis of pregnancy and to find out if Th-17 cells have a role
      in progress of intrahepatic cholestasis of pregnancy.
    

Detailed Description

      Intrahepatic cholestasis of pregnancy (ICP) is the most prevalent pregnancy-specific liver
      disease. It occurs mainly in the second or third trimester of pregnancy. It typically
      resolves after delivery spontaneously but it is associated with an increased risk of adverse
      fetal outcomes.

      The cause of ICP is heterogeneous, pathophysiology is poorly understood and therapies have
      been empiric. Genetic predispositions, environmental influences, dietary factors and hormonal
      influences have been studied and cited in the literature.

      Comparing with placebo, ursodeoxycholic acid (UDCA) has been shown improvement in treatment
      of pruritus in previous studies. S-adenosylmethionine, guar gum, activated charcoal,
      dexamethasone, cholestyramine, etc. are not effective in the treatment of symptoms.

      CD4+ T cells are an essential regulators of immune responses and inflammatory diseases. They
      are also called chief of orchestra cells of immune system. The balance between T
      helper-(Th)1, Th-2 and Th-17 cells and their cytokinergic interaction are crucial for the
      response of the organism. Th17 and its specific cytokine IL-17 are responsible for
      pathogenesis of autoimmune diseases as autoimmune uveitis, experimental autoimmune
      encephalomyelitis in animal models and potentially also in human autoimmune diseases such as
      multiple sclerosis, Crohn's disease, rheumatoid arthritis, psoriasis, primary biliary
      cirrhosis. Recently, IL-17 targeted therapies (secukinumab, ixekizumab and brodalumab) are
      being studied in Phase III clinical trials to evaluate their overall efficacy and safety for
      certain autoimmune diseases.

      Th-17 levels have been investigated in normal and abnormal pregnancies and results were
      incompatible with each other. Some researchers have said that the level of IL-17 increased
      during pregnancy but the others not.

      Low serum IL-17 is associated with premature birth. Up-regulation of the IL-17 is associated
      with preeclampsia.

      K. Harada et all. (2009) demonstrated that IL-17-positive cells are associated with the
      chronic inflammation of bile ducts in primary biliary cirrhosis(PBC). Also, some authors
      demonstrated that Th-17-related cytokines were increased significantly in patients with PBC.

      Maho Ichikawa et all. presented a case of male newborn infant who showed progressive severe
      cholestasis with selectively high Levels of Serum IL- 17.

      Based on all this information, we decided to investigate maternal and fetal serum IL-17
      levels of pregnants with ICP and the effects of UDCA therapy on it and find out if Th-17
      cells have a role in progress of ICP.
    


Study Type

Observational [Patient Registry]


Primary Outcome

il-17 levels


Condition

Intrahepatic Cholestasis of Pregnancy



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

30

Start Date

July 2013

Completion Date

July 2014

Primary Completion Date

June 2014

Eligibility Criteria

        Inclusion Criteria:

        Clinical diagnosis of ICP

        -

        Exclusion Criteria:

        multiple pregnancies known chronic illness
      

Gender

Female

Ages

18 Years - 39 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

ayse kirbas, md, + 90 533 646 92 13, [email protected]

Location Countries

Turkey

Location Countries

Turkey

Administrative Informations


NCT ID

NCT01898832

Organization ID

zekai tahir burak- cholestasis


Responsible Party

Principal Investigator

Study Sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital


Study Sponsor

ayse kirbas, md, Principal Investigator, Zekai Tahir Burak Women's Health Research and Education Hospital


Verification Date

July 2013