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Il-17 Levels in Intrahepatic Cholestasis of Pregnancy

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ClinicalTrials.gov Identifier: NCT01898832
Recruitment Status : Unknown
Verified July 2013 by Ayse Kirbas, Zekai Tahir Burak Maternity and Teaching Hospital.
Recruitment status was:  Recruiting
First Posted : July 12, 2013
Last Update Posted : March 18, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
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 Design

Study Type : Observational [Patient Registry]
Estimated Enrollment : 30 participants
Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: to Investigate the Maternal Serum IL-17 Levels in Pregnant Women With Intrahepatic Cholestasis of Pregnancy
Study Start Date : July 2013
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : July 2014


Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. il-17 levels [ Time Frame: 12 months ]

Biospecimen Retention:   None Retained
maternal venous ad umbilical cordon blood

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The pregnant women with intrahepatic cholestasis who admitted our clinic
Criteria

Inclusion Criteria:

Clinical diagnosis of ICP

Exclusion Criteria:

multiple pregnancies known chronic illness

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01898832


Contacts
Contact: ayse kirbas, md + 90 533 646 92 13 ayseozdemirkirbas@hotmail.com
Contact: ayse kirbas +90 312-306-5000

Locations
Turkey
Zekai Tahir Burak Recruiting
Ankara, Turkey, 06080
Contact: ayse kirbas, md    +90 533 646 92 13    ayseozdemirkirbas@hotmail.com   
Principal Investigator: ayse kirbas, md         
Sponsors and Collaborators
Zekai Tahir Burak Women's Health Research and Education Hospital
Investigators
Principal Investigator: ayse kirbas, md Zekai Tahir Burak Women's Health Research and Education Hospital
More Information

Responsible Party: Ayse Kirbas, ayse kirbas, Zekai Tahir Burak Maternity and Teaching Hospital
ClinicalTrials.gov Identifier: NCT01898832     History of Changes
Other Study ID Numbers: zekai tahir burak- cholestasis
First Posted: July 12, 2013    Key Record Dates
Last Update Posted: March 18, 2014
Last Verified: July 2013

Keywords provided by Ayse Kirbas, Zekai Tahir Burak Maternity and Teaching Hospital:
Cholestasis, pregnant, interleukin 17

Additional relevant MeSH terms:
Cholestasis
Cholestasis, Intrahepatic
Pregnancy Complications
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Liver Diseases