Status:
COMPLETED
Gut Microbiota In Children With Autoimmune Liver Disease and Its Effect on Treatment Response
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
Autoimmune Diseases
Eligibility:
All Genders
12-18 years
Brief Summary
Gut microbiota and liver disease are very closely linked. Microbiota influences the various liver diseases by Dysbiosis ratio .There is loss of tolerance targeting liver antigens which is thought to i...
Detailed Description
Aim and Objective - To compare the gut microbiota (dysbiosis ratio, alpha and beta diversity, Shannon index) in children with autoimmune liver disease versus those with Wilson disease, and study its i...
Eligibility Criteria
Inclusion
- Disease cohort: Children with evidence of chronic liver disease with autoimmune Liver disease and Wilson disease (hepatic involvement).
- Control cohort: Age and socio-economic status matched healthy children under-18-year age with
- Wilson disease: Diagnosis as per AASLD guidelines i.e. presence of either 3 of the following: Kayser Fleischer ring in cornea, 24-hour urine copper \>40 microgm /day, serum ceruloplasmin \<20 mg/dL; Leipzig score \>4 or presence of one homozygous or 2 or more compound heterozygous disease causing mutations in ATP7B gene.
- Autoimmune liver disease: Diagnosis on the basis of presence of abnormalities in transaminases with hypergammaglobinemia, positive autoantibodies (anti-nuclear, anti-smooth muscle, anti-liver-kidney-microsomal, anti-soluble liver antigen), suggestive liver biopsy (interface hepatitis, plasma cell infiltrates, emperipolesis, pseudorosettes) in absence of other known causes of liver disease (viral hepatitis, Wilson disease, Budd-Chiari syndrome, etc) and simplified score ≥ 6
Exclusion
- Antibiotic usage for last 1 week or immunosuppression usage for last 4 weeks
- Liver tumours
- Active or recent episode of gastroenteritis within 1 week of presentation
- Diabetes mellitus
- Primary and secondary immunodeficiency states (HIV)
- Abdominal surgery
- Usage of proton pump inhibitors in last 1 week.
- Uncertain diagnosis or incomplete work-up
Key Trial Info
Start Date :
November 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06183190
Start Date
November 1 2023
End Date
December 31 2024
Last Update
July 9 2025
Active Locations (1)
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1
Institute of Liver & Biliary Sciences (ILBS)
New Delhi, National Capital Territory of Delhi, India, 110070