Bile Acids Metabolism and Genetic Mutation Profile in the ICP in the Indian Population

Launched by POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH · Jan 17, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a condition called Intrahepatic Cholestasis of Pregnancy (ICP), which causes severe itching and can lead to higher risks for both mothers and their babies during pregnancy. The study focuses on how bile acids, which are substances in the body related to digestion, and certain genetic factors may impact the health of pregnant women in India who experience this condition. The aim is to understand how ICP affects their overall quality of life and to gather important health information.

To participate in this trial, women over the age of 21 who are experiencing persistent itching and have elevated liver enzymes or bile acids may be eligible. Participants will need to give their consent to be part of the study and agree to share information about their pregnancy outcomes. The trial is currently recruiting participants, and those who join can expect to be monitored until their delivery, contributing valuable insights into the health effects of ICP. It’s important to note that women with certain liver diseases, infections, or multiple pregnancies (like twins or triplets) will not be able to take part in this study.

Gender

FEMALE

Eligibility criteria

• • Inclusion Criteria -
• • Age \> 21 years with consistent pruritus
• • Characterized by consistent pruritus associated with elevated levels of serum transaminases (ALT \> 40 U/L or AST \> 37 U/L) or raised total serum bile acids (≥ 10 µmol/L)
• • Able to understand and comply with the requirements of the study and voluntarily agrees to participate in the study by giving written informed consent before any study-related activity is performed
• • Voluntary informed consent to participate until their delivery and also willing to be followed until their delivery
• • Agrees to provide information on perinatal and maternal outcomes at or after delivery
• Exclusion Criteria:
• • Viral and Infectious diseases such as hepatitis B virus (HBV), hepatitis C virus (HCV) related liver disease, Epstein Barr virus (EBV), Cytomegalovirus (CMV), human immunodeficiency virus (HIV) infection) hepatitis C virus (HBV), hepatitis E virus (HEV)
• • Primary dermatologic diseases associated with pruritus
• • Metabolic diseases (including alcohol abuse)
• • Other causes of cholestasis (i.e., primary biliary cholangitis (PBC); primary sclerosing cholangitis (PSC)
• • Autoimmune liver disease
• • Obstructive biliary diseases
• • Cholestatic drug-induced liver injury
• • Clinical severe conditions that may affect outcomes include heart failure, renal failure, primary cardiopulmonary diseases
• • Twins and triplet pregnancy