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

NCT07118657 | Not Yet Recruiting

• 1 other identifier: ILBS-AIH-03
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Pediatric autoimmune liver diseases (AILDs), including autoimmune hepatitis (AIH) and overlap syndromes like sclerosing cholangitis, are among the most common chronic liver conditions in the pediatric population. Currently, the treatment for AIH often involves long-term use of immunosuppressive therapy, which carries risks of severe side effects both in the short and long term. Due to these potential adverse effects, there is a critical need to explore alternative therapies that can modulate autoimmunity and potentially reduce or eliminate the dependence on immunosuppressive drugs. Autoimmune diseases, including AIH, typically arise in genetically predisposed individuals after exposure to certain environmental factors, leading to a breakdown in self-tolerance.The gut microbiome plays a crucial role in modulating the immune system through both anti-inflammatory and pro-inflammatory pathways. In advanced liver diseases, factors such as intestinal dysmotility, small intestinal bacterial overgrowth (SIBO), and increased intestinal permeability contribute to enhanced bacterial translocation, consistent with the "leaky gut" hypothesis. This phenomenon allows the passage of toxins, antigens, and bacteria into the systemic circulation, potentially exacerbating autoimmune responses. Consequently, altering the gut microbiome through dietary changes, probiotics, prebiotics, or fecal microbiota transplantation presents a promising therapeutic approach for autoimmune diseases.This study aims to investigate the gut microbiome and its modification following dietary intervention (specifically, a plant-based vegan diet) in pediatric AIH. Additionally, investigator will explore the potential role of such interventions in managing intestinal dysfunction in patients with advanced liver disease. In Aim 1, investigator will compare the baseline gut microbiome profiles of treatment-naïve pediatric AIH patients with those of healthy, age- and sex-matched controls to provide foundational insights. In Aim 2, investigator will evaluate the proportion of patients achieving biochemical remission after 180 days of a vegan versus standard diet in AIH patients. Investigator will also assess changes in stool metagenomics, metabolomics, cytokine profiles, gut epithelial barrier function, and liver disease severity scores between the two dietary groups. This study aims to demonstrate the potential benefits of a vegan diet in managing autoimmune hepatitis. It seeks to provide evidence supporting dietary modifications as a complementary approach to standard medical treatments for a wide range of autoimmune or autoimmune-like disorders, potentially paving the way for future therapeutic strategies.

Conditions

Autoimmune Hepatitis

Outcome Measures

Primary Outcomes (1)

• Proportion of patients achieving biochemical remission after 180 days of vegan and standard high protein diet in treatment naive pediatric subjects with autoimmune hepatitis.

  biochemical remission is defined as normalization of both serum AST/ALT \& serum IgG. high protein (2-3 g/kg/day)

  180 days

Secondary Outcomes (6)

• Change in stool metagenome (after 180 daysof plant based (vegan) vs. standard high protein diet along with standard medical management including immunosuppression in treatment naive pediatric subjects with autoimmune hepatitis).

  180 days

• Change in stool metabolome (after 180 daysof plant based (vegan) vs. standard high protein diet along with standard medical management including immunosuppression in treatment naive pediatric subjects with autoimmune hepatitis).

  180 days

• Change in stool & blood cytokines (after 180 daysof plant based (vegan) vs. standard high protein diet along with standard medical management including immunosuppression in treatment naive pediatric subjects with autoimmune hepatitis).

  180 days

• Change in blood flow cytometry (after 180 daysof plant based (vegan) vs. standard high protein diet along with standard medical management including immunosuppression in treatment naive pediatric subjects with autoimmune hepatitis).

  180 days

• Change in Gut Epithelial Barrier Function (after 180 daysof plant based (vegan) vs. standard high protein diet along with standard medical management including immunosuppression in treatment naive pediatric subjects with autoimmune hepatitis).

  180 days

Study Arms (2)

Vegan Diet

EXPERIMENTAL

Other: Vegan Diet

Standard Diet

ACTIVE COMPARATOR

Other: Standard Diet

Interventions

Vegan Diet OTHER

Vegan diet would be defined as a diet based solely of plant 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 along with calcium (50-75 mg/kg/day), vitamin D (800-1600 IU/day) and iron supplementation (3-6 mg/kg/day) as per requirement. o 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).

Vegan Diet

Standard Diet OTHER

Standard Diet

Standard Diet

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Cases diagnosed as Autoimmune hepatitis (AIH).
• Controls are healthy subjects.

You may not qualify if:

• Recent (\< 6 weeks) exposure to oral or intravenous antibiotics, probiotics/prebiotics, proton pump inhibitors, or herbal medicines.
• Any history of malignancy or any gastrointestinal tract surgery.
• Recent (\< 2 weeks) gastrointestinal infection.
• Any dietary allergies .

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences

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

Location

MeSH Terms

Conditions

Hepatitis, Autoimmune

Interventions

Diet, Vegan

Condition Hierarchy (Ancestors)

Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diet, Vegetarian; Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Dr Vikrant Sood, DM

CONTACT

01146300000; drvickyster@gmail.com

Dr Seema Alam, MD

CONTACT

01146300000; seema_alam@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: August 12, 2025
• Study Start: September 10, 2025
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: August 12, 2025

Record last verified: 2025-05

Locations

IN (1)