Host-Diet-Gut Interaction Post Vegan Diet in Pediatric Autoimmune Hepatitis

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2025
Hypothesis/Research Question: 1. P = Population/Patient/Problem ‐ Pediatric patients (< 18 years of age) withAutoimmune Hepatitis 2. I = Intervention ‐Vegan diet for 180 days (in addition of standard immunosuppressivemedical therapy) 3. C = Comparison ‐ Standard High Protein diet for 180 days (in addition of standardimmunosuppressivemedical therapy) 4. O = Outcome ‐ Proportion of subjects achieving biochemical remission; change instool metagenome/metabolome/cytokines, gut epithelial barrier function, and liverdisease severity scores between the two study groups.Methodology:Place: Department of Pediatric Hepatology &Molecular and Cellular Medicine, Institute ofLiver and Biliary Sciences, New Delhi ‐ Study design: Prospective, Randomized, Single center, Open label study ‐ Study period: October 2024 to October 2027 Details of the diets (Vegan diet andStandard High Protein diet) Vegan diet would be defined as a diet based solely ofplant products with exclusion of all animal products including meat, fish, dairy,honey and eggs. ‐ Additional supplementation of vitamin B12 (500 µg/day) in the vegan diet group alongwith calcium (50‐75 mg/kg/day), vitamin D (800��1600 IU/day) and iron supplementation(3‐6 mg/kg/day) as per requirement. ‐ Monitoring‐ Based on vitamin B12 levels, 25(OH) vitamin D3 levels, serum calcium, and serum iron studies (complete hemogram, ferritin, iron, transferrin saturation, total iron binding capacity).
Epistemonikos ID: 13422640805947fec8efcb7a747b161503275e8a
First added on: Aug 13, 2025