Effect of vegetarian diet on gut bacteria in Pediatric Autoimmune Hepatitis (Liver Disease).

Not yet recruiting

Conditions: Autoimmune hepatitis,

Registration Number: CTRI/2025/06/089090

Lead Sponsor: Institute of Liver and Biliary Sciences

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, we will explore the potential role of such interventions in managing intestinal dysfunction in patients with advanced liver disease. In Aim 1, we 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, we will evaluate the proportion of patients achieving biochemical remission after 180 days of a vegan versus standard diet in AIH patients. We 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

1.Cases (age less than 18 years): a.Patients diagnosed as Autoimmune hepatitis (AIH)- b.Diagnosis based on year simplified diagnostic criteria of International Autoimmune Hepatitis Group (IAIHG) (Score more than 7 as definite AIH) i.Components include liver histology, auto-antibodies, serum IgG levels and absence of superimposed viral hepatitis 2.Controls (age less than 18 years): a.
Healthy subjects with no hepatobiliary or other pathology.

Exclusion Criteria

1.Recent (less than 6 weeks) exposure to oral or intravenous antibiotics, probiotics or prebiotics, proton pump inhibitors, or herbal medicines 2.Any history of malignancy or any gastrointestinal tract surgery 3.Recent (less than 2 weeks) gastrointestinal infection 4.Any dietary allergies.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the proportion of patients achieving biochemical remission (normalization of both serum AST/ALT & serum IgG) after 180 days of vegan and standard high protein (2-3 g/kg/day) diet in treatment naive pediatric subjects with autoimmune hepatitis (along with standard medical management including immunosuppression).	180 days

Secondary Outcome Measures

Name	Time	Method
To compare the change vegan vs. standard high protein diet along with standard medical management including immunosuppression in treatment naive pediatric subjects with autoimmune hepatitis) in:	a.Stool Metagenome

Trial Locations

Locations (1): Institute of Liver and Biliary Sciences
🇮🇳
West, DELHI, India
Institute of Liver and Biliary Sciences
🇮🇳West, DELHI, India
Dr Vikrant Sood
Principal investigator
01146300000
drvickyster@gmail.com