Gut Microbiota In Children With Autoimmune Liver Disease and Its Effect on Treatment Response (NCT06183190) | Clinical Trial Compass
CompletedNot Applicable
Gut Microbiota In Children With Autoimmune Liver Disease and Its Effect on Treatment Response
India45 participantsStarted 2023-11-01
Plain-language 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.
Who can participate
Age range12 Years – 18 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. Antibiotic usage for last 1 week or immunosuppression usage for last 4 weeks
✕. Liver tumours
What they're measuring
1
To compare the gut microbiota in children with autoimmune Liver disease and those with Wilson disease and age matched healthy controls.
Timeframe: Day 0 & 6 months
Trial details
NCT IDNCT06183190
SponsorInstitute of Liver and Biliary Sciences, India