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CTRI Number  CTRI/2025/06/089090 [Registered on: 18/06/2025] Trial Registered Prospectively
Last Modified On: 18/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Dietary Intervention]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of vegetarian diet on gut bacteria in Pediatric Autoimmune Hepatitis (Liver Disease). 
Scientific Title of Study   Host-Diet-Gut Interaction Post Vegan Diet in Pediatric Autoimmune Hepatitis. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
None  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vikrant Sood 
Designation  Associate Professor, Pediatric Hepatology 
Affiliation  Institute of Liver and Biliary Sciences 
Address  Room No. 3317, Department of Pediatric Hepatology, Phase II, 3rd Floor, D-1, Vasant Kunj, New Delhi-110070.

South West
DELHI
110070
India 
Phone  01146300000  
Fax    
Email  drvickyster@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Seema Alam 
Designation  Professor & Head, Department of Pediatric Hepatology 
Affiliation  Institute of Liver and Biliary Sciences 
Address  Room No. 3326, Department of Pediatric Hepatology, Phase II, 3rd Floor, D-1, Vasant Kunj, New Delhi-110070.

South West
DELHI
110070
India 
Phone  01146300000  
Fax    
Email  seema_alam@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Seema Alam 
Designation  Professor & Head, Department of Pediatric Hepatology 
Affiliation  Institute of Liver and Biliary Sciences 
Address  Room No. 3326, Department of Pediatric Hepatology, Phase II, 3rd Floor, D-1, Vasant Kunj, New Delhi-110070.


DELHI
110070
India 
Phone  01146300000  
Fax    
Email  seema_alam@hotmail.com  
 
Source of Monetary or Material Support  
ILBS,D-1,Vasant Kunj, New Delhi-110070. 
 
Primary Sponsor  
Name  Institute of Liver and Biliary Sciences 
Address  D-1, Vasant Kunj, New Delhi-110070. 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vikrant Sood  Institute of Liver and Biliary Sciences  Room No. 3317, Department of Pediatric Hepatology, Phase II, 3rd Floor, D-1, Vasant Kunj, New Delhi-110070.
South West
DELHI 
01146300000

drvickyster@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, ILBS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K754||Autoimmune hepatitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Standard Diet  Standard Diet 
Intervention  Vegan Diet  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. 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  18.00 Month(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
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  
Outcome  TimePoints 
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
b. Stool Metabolome
c. Stool and Blood Cytokines
d. Blood Flow Cytometry
e. Gut Epithelial Barrier Function:
i. Duodenal Histology (when available)
ii. Fecal protein loss/inflammation-
f. Disease severity scores and Liver stiffness (LSM) values.
 
180 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/06/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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.
 
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