Gut Microbiota In Children With Autoimmune Liver Disease and Its Effect on Treatment Response

NCT06183190 | Completed

• 1 other identifier: ILBS-AIH-01
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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 initiate disease in genetically susceptible individuals. This is triggered by environmental agents such as pathogens.Autoimmune Liveer disease(AILD )patients have Specific bacterial profile and Alterations in bacterial metabolites and immune pathways trigger Autoimmune hepatitis( AIH)\& lead to its progression .Apoptosis of intestinal epithelial cells in response to microbial stimuli presentation of self-antigens leading to differentiation of autoreactive Th17 cells and other T helper cells leading to T-cell response of AILD.(1). Disease-associated dysbiosis in untreated patients with AIH was characterised by reduced biodiversity, decreased abundance of anaerobes and increase of the genera Veillonella, Klebsiella, Streptococcus and Lactobacillus(2-3).It remains unclear whether this microbial signature is specific compared to other autoimmune liver diseases or other immune-mediated diseases, and whether it is reproducible across geographic borders .However there is Scarce paediatric data comparing gut microbiota in AILD vs other liver diseases and no data on role of gut microbiota on response to treatment in AILD . The aim of this study will be to To compare the gut microbiota (dysbiosis ratio, alpha and beta diversity, Shannon index) in children with autoimmune liver disease and Wilson disease, and study its influence on response to treatment in children with autoimmune liver disease.

Conditions

Autoimmune Diseases

Outcome Measures

Primary Outcomes (1)

• To compare the gut microbiota in children with autoimmune Liver disease and those with Wilson disease and age matched healthy controls.

  Day 0 & 6 months

Secondary Outcomes (3)

• Inflammatory markers (TNF-alpha, IL-6)

  Day 0

• Markers of bacterial infection (Plasma endotoxin, CRP, Procalcitonin)

  Day 0

• Gut microbiota in children with AILD with easy to treat versus difficult to treat AIH (persistent elevation of AST & ALT above 1.5 times upper limit of normal at 6 months of initiation of treatment)

  Day 0

Study Arms (3)

Autoimmune Liver Disease

Autoimmune Liver Disease

Other: No intervention

Wilsons Disease

Wilsons Disease

Other: No intervention

Healthy Control

Healthy Control

Other: No intervention

Interventions

No intervention OTHER

No intervention

Autoimmune Liver Disease; Healthy Control; Wilsons Disease

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

* Study population:Disease cohort: Children with evidence of chronic liver disease with autoimmune Liver disease and Wilson disease (hepatic involvement) under 18 years of age * Control cohort: Agematched healthy children under-18-year age with

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences (ILBS)

New Delhi, National Capital Territory of Delhi, 110070, India

Location

Biospecimen

Retention: SAMPLES WITH DNA

RNA isolation from the stool samples for 16 s

MeSH Terms

Conditions

Autoimmune Diseases

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: December 27, 2023
• Study Start: November 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 9, 2025

Record last verified: 2023-12

Locations

IN (1)