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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/089090
Enrollment
40
Registered
2025-06-18
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K754- Autoimmune hepatitis

Interventions

Intervention1: 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. Control Intervention1

Sponsors

Institute of Liver and Biliary Sciences
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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).Timepoint: 180 days—

Secondary

MeasureTime frame
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. Timepoint: 180 days—

Countries

India

Contacts

Public ContactDr Seema Alam

Institute of Liver and Biliary Sciences

seema_alam@hotmail.com01146300000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026