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
|
|
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
|
|
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. |