Autoimmune HepatitisNCT07118657
Host-Diet-Gut Interaction Post Vegan Diet in Pediatric Autoimmune Hepatitis.
A study testing Vegan Diet and Standard Diet in people with Autoimmune Hepatitis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Autoimmune Hepatitis
- What is being tested?
- Vegan Diet and Standard Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- 11 Feb 2026to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Cases diagnosed as Autoimmune hepatitis (AIH).
- Controls are healthy subjects.
Who cannot join
- Recent (< 6 weeks) exposure to oral or intravenous antibiotics, probiotics/prebiotics, proton pump inhibitors, or herbal medicines.
- Any history of malignancy or any gastrointestinal tract surgery.
- Recent (< 2 weeks) gastrointestinal infection.
- Any dietary allergies .
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
Dr Vikrant Sood, DM, 01146300000, drvickyster@gmail.com
About this study
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, investigator will explore the potential role of such interventions in managing intestinal dysfunction in patients with advanced liver disease. In Aim 1, investigator 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, investigator will evaluate the proportion of patients achieving biochemical remission after 180 days of a vegan versus standard diet in AIH patients. Investigator 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.
Read the detailed description
Hypothesis/Research Question:
- P = Population/Patient/Problem - Pediatric patients (< 18 years of age) with Autoimmune Hepatitis
- I = Intervention -Vegan diet for 180 days (in addition of standard immunosuppressive medical therapy)
- C = Comparison - Standard High Protein diet for 180 days (in addition of standard immunosuppressivemedical therapy)
- O = Outcome - Proportion of subjects achieving biochemical remission; change in stool metagenome/metabolome/cytokines, gut epithelial barrier function, and liver disease severity scores between the two study groups.
Methodology:
Place: Department of Pediatric Hepatology \&Molecular and Cellular Medicine, Institute of Liver and Biliary Sciences, New Delhi
- Study design: Prospective, Randomized, Single center, Open label study
- Study period: October 2024 to October 2027 Details of the diets (Vegan diet and Standard High Protein 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.
- Additional supplementation of vitamin B12 (500 µg/day) in the vegan diet group along with calcium (50-75 mg/kg/day), vitamin D (800-1600 IU/day) and iron supplementation (3-6 mg/kg/day) as per requirement.
- Monitoring- Based on vitamin B12 levels, 25(OH) vitamin D3 levels, serum calcium, and serum iron studies (complete hemogram, ferritin, iron, transferrin saturation, total iron binding capacity).
- Conditions
- Autoimmune Hepatitis
- Being tested
- Vegan Diet, Standard Diet
- Medical subject headings
- Hepatitis, Autoimmune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vegan DietOther
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.• Additional supplementation of vitamin B12 (500 µg/day) in the vegan diet group along with calcium (50-75 mg/kg/day), vitamin D (800-1600 IU/day) and iron supplementation (3-6 mg/kg/day) as per requirement.
- Monitoring- Based on vitamin B12 levels, 25(OH) vitamin D3 levels, serum calcium, and serum iron studies (complete hemogram, ferritin, iron, transferrin saturation, total iron binding capacity).
Standard DietOther
Standard Diet
| Study group | Role | What they receive |
|---|---|---|
| Vegan Diet | Experimental | Not described Receives: Other: Vegan Diet |
| Standard Diet | Active comparator | Not described Receives: Other: Standard Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving biochemical remission after 180 days of vegan and standard high protein diet in treatment naive pediatric subjects with autoimmune hepatitis.
biochemical remission is defined as normalization of both serum AST/ALT \& serum IgG.
high protein (2-3 g/kg/day)
Measured: 180 days
Secondary outcomes (6)
Change in stool metagenome (after 180 daysof plant based (vegan) vs. standard high protein diet along with standard medical management including immunosuppression in treatment naive pediatric subjects with autoimmune hepatitis).
Measured: 180 days
Change in stool metabolome (after 180 daysof plant based (vegan) vs. standard high protein diet along with standard medical management including immunosuppression in treatment naive pediatric subjects with autoimmune hepatitis).
Measured: 180 days
Change in stool & blood cytokines (after 180 daysof plant based (vegan) vs. standard high protein diet along with standard medical management including immunosuppression in treatment naive pediatric subjects with autoimmune hepatitis).
Measured: 180 days
Change in blood flow cytometry (after 180 daysof plant based (vegan) vs. standard high protein diet along with standard medical management including immunosuppression in treatment naive pediatric subjects with autoimmune hepatitis).
Measured: 180 days
Change in Gut Epithelial Barrier Function (after 180 daysof plant based (vegan) vs. standard high protein diet along with standard medical management including immunosuppression in treatment naive pediatric subjects with autoimmune hepatitis).
Measured: 180 days
Change in liver disease severity score (after 180 daysof plant based (vegan) vs. standard high protein diet along with standard medical management including immunosuppression in treatment naive pediatric subjects with autoimmune hepatitis).
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start11 Feb 2026
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune HepatitisStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07118657
- Sponsor's protocol ID
- ILBS-AIH-03
- Status last verified
- Jun 2026
- First submitted
- 8 May 2025
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Host-Diet-Gut Interaction Post Vegan Diet in Pediatric Autoimmune Hepatitis.
- ClinicalTrials.gov ID
- NCT07118657
- Acronym / sponsor ID
- ILBS-AIH-03
- Conditions
- Autoimmune Hepatitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 11 Feb 2026 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 12 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, investigator will explore the potential role of such interventions in managing intestinal dysfunction in patients with advanced liver disease. In Aim 1, investigator 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, investigator will evaluate the proportion of patients achieving biochemical remission after 180 days of a vegan versus standard diet in AIH patients. Investigator 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
Hypothesis/Research Question:
- P = Population/Patient/Problem - Pediatric patients (< 18 years of age) with Autoimmune Hepatitis
- I = Intervention -Vegan diet for 180 days (in addition of standard immunosuppressive medical therapy)
- C = Comparison - Standard High Protein diet for 180 days (in addition of standard immunosuppressivemedical therapy)
- O = Outcome - Proportion of subjects achieving biochemical remission; change in stool metagenome/metabolome/cytokines, gut epithelial barrier function, and liver disease severity scores between the two study groups.
Methodology:
Place: Department of Pediatric Hepatology \&Molecular and Cellular Medicine, Institute of Liver and Biliary Sciences, New Delhi
- Study design: Prospective, Randomized, Single center, Open label study
- Study period: October 2024 to October 2027 Details of the diets (Vegan diet and Standard High Protein 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.
- Additional supplementation of vitamin B12 (500 µg/day) in the vegan diet group along with calcium (50-75 mg/kg/day), vitamin D (800-1600 IU/day) and iron supplementation (3-6 mg/kg/day) as per requirement.
- Monitoring- Based on vitamin B12 levels, 25(OH) vitamin D3 levels, serum calcium, and serum iron studies (complete hemogram, ferritin, iron, transferrin saturation, total iron binding capacity).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vegan Diet | Experimental | Other: Vegan Diet |
| Standard Diet | Active comparator | Other: Standard Diet |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Cases diagnosed as Autoimmune hepatitis (AIH).
- Controls are healthy subjects.
Key exclusion criteria (4 listed)
- Recent (< 6 weeks) exposure to oral or intravenous antibiotics, probiotics/prebiotics, proton pump inhibitors, or herbal medicines.
- Any history of malignancy or any gastrointestinal tract surgery.
- Recent (< 2 weeks) gastrointestinal infection.
- Any dietary allergies .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vegan DietVegan 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.• Additional supplementation of vitamin B12 (500 µg/day) in the vegan diet group along with calcium (50-75 mg/kg/day), vitamin D (800-1600 IU/day) and iron supplementation (3-6 mg/kg/day) as per requirement. o Monitoring- Based on vitamin B12 levels, 25(OH) vitamin D3 levels, serum calcium, and serum iron studies (complete hemogram, ferritin, iron, transferrin saturation, total iron binding capacity). | Other | Vegan Diet |
| Standard DietStandard Diet | Other | Standard Diet |
Primary outcome
Proportion of patients achieving biochemical remission after 180 days of vegan and standard high protein diet in treatment naive pediatric subjects with autoimmune hepatitis.
Time frame: 180 days
biochemical remission is defined as normalization of both serum AST/ALT \& serum IgG. high protein (2-3 g/kg/day)
6 secondary outcomes
Change in stool metagenome (after 180 daysof plant based (vegan) vs. standard high protein diet along with standard medical management including immunosuppression in treatment naive pediatric subjects with autoimmune hepatitis).
Time frame: 180 days
Change in stool metabolome (after 180 daysof plant based (vegan) vs. standard high protein diet along with standard medical management including immunosuppression in treatment naive pediatric subjects with autoimmune hepatitis).
Time frame: 180 days
Change in stool & blood cytokines (after 180 daysof plant based (vegan) vs. standard high protein diet along with standard medical management including immunosuppression in treatment naive pediatric subjects with autoimmune hepatitis).
Time frame: 180 days
Change in blood flow cytometry (after 180 daysof plant based (vegan) vs. standard high protein diet along with standard medical management including immunosuppression in treatment naive pediatric subjects with autoimmune hepatitis).
Time frame: 180 days
Change in Gut Epithelial Barrier Function (after 180 daysof plant based (vegan) vs. standard high protein diet along with standard medical management including immunosuppression in treatment naive pediatric subjects with autoimmune hepatitis).
Time frame: 180 days
Change in liver disease severity score (after 180 daysof plant based (vegan) vs. standard high protein diet along with standard medical management including immunosuppression in treatment naive pediatric subjects with autoimmune hepatitis).
Time frame: 180 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vegan Diet and Standard Diet in people with Autoimmune Hepatitis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Vikrant Sood, DM (01146300000, drvickyster@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients achieving biochemical remission after 180 days of vegan and standard high protein diet in treatment naive pediatric subjects with autoimmune hepatitis. (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.