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Research on the Role and Mechanism of Gut Microbiota in ICP Based on the FXR/FGF19 Pathway

The mechanism of FXR-mediated FGF19/CYP7A1 pathway regulating bile acid metabolism in intrahepatic cholestasis of pregnancy

Status
Active, not recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400083629
Enrollment
Unknown
Registered
2024-04-29
Start date
2024-05-01
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

intrahepatic cholestasis of pregnancy, ICP

Interventions

control group:None
Study group:none

Sponsors

The Third Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: ? The diagnostic criteria for ICP refer to the "Guidelines for the Diagnosis and Treatment of Intrahepatic Cholestasis of Pregnancy (2015)"; ? Primiparas or multiparas aged between 18 and 40 years old; ? Singleton pregnancy; ? Those who have not received ICP drug treatment during the collection of biological samples between the 28th and 34th weeks of pregnancy. Inclusion criteria for the 60 control group: singleton healthy pregnant women matched in a 1:1 ratio based on the age and gestational weeks of ICP patients (with no comorbid medical or surgical diseases and pregnancy

Exclusion criteria

Exclusion criteria: ? Multiple pregnancies; ? History of hepatobiliary and other digestive system diseases, or history of other liver damage; ? History of hypertension, diabetes, hyperthyroidism, rheumatic diseases, mental illness, other autoimmune diseases, and endocrine and metabolic diseases; ? Long-term use of antibiotics, immunosuppressive agents, and other drugs during pregnancy; ? History of blood transfusion, organ transplantation or immunotherapy; ? Not willing to participate in this study, or not willing to provide stool and blood samples for this study

Design outcomes

Primary

MeasureTime frame
bile acids ;

Secondary

MeasureTime frame
Liver function;

Countries

China

Contacts

Public ContactZhenyan Han

The Third Affiliated Hospital of Sun Yat-sen University

huangmli5@mail.sysu.edu.cn+86 139 2601 1165

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026