Pediatric autoimmune hepatitis: can a vegan diet reduce reliance on immunosuppressants
Official title: Host-Diet-Gut Interaction Post Vegan Diet in Pediatric Autoimmune Hepatitis.
Run by Institute of Liver and Biliary Sciences, India · NCT07118657 · Data updated 2026-11-12
In children with autoimmune hepatitis, this study tests whether adding a vegan diet for six months to standard treatment can help achieve liver disease remission compared with a standard high-protein diet.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 0 Years to 18 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Institute of Liver and Biliary Sciences, India Academic / other |
| Locations | 1 site (New Delhi, National Capital Territory of Delhi) |
| Status | Recruiting |
| Started | February 11, 2026 |
| Main results expected | April 30, 2028 |
| Study ends | April 30, 2028 |
| Registry record updated | June 12, 2026 |
| Trial ID | NCT07118657 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children under 18 diagnosed with autoimmune hepatitis who can adhere to either diet and have not recently used antibiotics or probiotics.
✕Probably not a fit
Patients who do not respond to dietary change or who have conditions interfering with diet adherence may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, randomized, single-center, open-label study in New Delhi. Pediatric AIH patients will be assigned to a vegan plant-based diet or a standard high-protein diet for 180 days, in addition to their usual immunosuppressive therapy. The trial will monitor biochemical remission and analyze changes in gut microbiome, metabolites, cytokines, gut barrier function, and liver disease scores. Supplementary vitamins and minerals (B12, D, calcium, iron) will be provided as needed with periodic blood tests. Enrollment is limited to AIH patients and excludes recent antibiotic/probiotic use or other conditions that could affect diet tolerance or liver health.
Why it matters
Potential benefit: If successful, the diet intervention could help reduce the need for long-term immunosuppressants in pediatric AIH.
How similar studies have gone: There is growing interest in diet-microbiome interactions for autoimmune diseases, but data in pediatric AIH are limited, making this approach exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Cases diagnosed as Autoimmune hepatitis (AIH). 2. Controls are healthy subjects. Exclusion Criteria: 1. Recent (\< 6 weeks) exposure to oral or intravenous antibiotics, probiotics/prebiotics, proton pump inhibitors, or herbal medicines. 2. Any history of malignancy or any gastrointestinal tract surgery. 3. Recent (\< 2 weeks) gastrointestinal infection. 4. Any dietary allergies .
Where it's running
-
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India Recruiting
Study contacts
- Study coordinator: Dr Vikrant Sood, DM
- Email: drvickyster@gmail.com
- Phone: 01146300000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.