Actively Recruiting
Effect of a Vegan Diet on Gut Microbiome and Liver Health in Children with Autoimmune Hepatitis
Led by Institute of Liver and Biliary Sciences, India · Updated on 2026-06-12
40
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Pediatric autoimmune liver diseases, including autoimmune hepatitis AIH and overlap syndromes like sclerosing cholangitis, are common chronic liver conditions in children. This trial evaluates how modifying the gut microbiome with a plant-based vegan diet might impact pediatric AIH, aiming to reduce reliance on long-term immunosuppressive therapy that carries risks of side effects. The study compares gut microbiome profiles and biochemical remission rates between treatment-naive AIH patients and healthy controls. Participants are randomized to follow either a vegan diet or a standard high-protein diet for 180 days alongside their usual immunosuppressive treatments. The vegan diet excludes all animal products and includes supplements such as vitamin B12, calcium, vitamin D, and iron as needed. The study is conducted at a single center and monitors vitamin and mineral levels during the intervention. During the study, stool and blood samples are collected to analyze changes in the microbiome, metabolomics, cytokines, gut barrier function, and liver disease severity scores. The main outcome is the proportion of patients achieving biochemical remission after 180 days on the diets. Participants are closely monitored throughout the study period lasting up to 180 days, with assessments of immune markers and overall liver health.
CONDITIONS
Brief Title
Host-Diet-Gut Interaction Post Vegan Diet in Pediatric Autoimmune Hepatitis.
Research Team
D
Dr Vikrant Sood, DM
D
Dr Seema Alam, MD
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