Autoimmune DiseasesNCT06183190
Gut Microbiota In Children With Autoimmune Liver Disease and Its Effect on Treatment Response
An observational study of Autoimmune Diseases, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Gut microbiota and liver disease are very closely linked. Microbiota influences the various liver diseases by Dysbiosis ratio .There is loss of tolerance targeting liver antigens which is thought to initiate disease in genetically susceptible individuals. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Autoimmune Diseases
- How many people
- 45 participants
- Where
- 1 siteIndia
- Study dates
- 1 Nov 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: * Study population:Disease cohort: Children with evidence of chronic liver disease with autoimmune Liver disease and Wilson disease (hepatic involvement) under 18 years of age * Control cohort: Agematched healthy children under-18-year age with
Who may be able to join
- Disease cohort: Children with evidence of chronic liver disease with autoimmune Liver disease and Wilson disease (hepatic involvement).
- Control cohort: Age and socio-economic status matched healthy children under-18-year age with
- Wilson disease: Diagnosis as per AASLD guidelines i.e. presence of either 3 of the following: Kayser Fleischer ring in cornea, 24-hour urine copper >40 microgm /day, serum ceruloplasmin <20 mg/dL; Leipzig score >4 or presence of one homozygous or 2 or more compound heterozygous disease causing mutations in ATP7B gene.
- Autoimmune liver disease: Diagnosis on the basis of presence of abnormalities in transaminases with hypergammaglobinemia, positive autoantibodies (anti-nuclear, anti-smooth muscle, anti-liver-kidney-microsomal, anti-soluble liver antigen), suggestive liver biopsy (interface hepatitis, plasma cell infiltrates, emperipolesis, pseudorosettes) in absence of other known causes of liver disease (viral hepatitis, Wilson disease, Budd-Chiari syndrome, etc) and simplified score ≥ 6
Who cannot join
- Antibiotic usage for last 1 week or immunosuppression usage for last 4 weeks
- Liver tumours
- Active or recent episode of gastroenteritis within 1 week of presentation
- Diabetes mellitus
- Primary and secondary immunodeficiency states (HIV)
- Abdominal surgery
- Usage of proton pump inhibitors in last 1 week.
- Uncertain diagnosis or incomplete work-up
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver & Biliary Sciences (ILBS)
New Delhi, National Capital Territory of Delhi, 110070
About this study
Gut microbiota and liver disease are very closely linked. Microbiota influences the various liver diseases by Dysbiosis ratio .There is loss of tolerance targeting liver antigens which is thought to initiate disease in genetically susceptible individuals. This is triggered by environmental agents such as pathogens.Autoimmune Liveer disease(AILD )patients have Specific bacterial profile and Alterations in bacterial metabolites and immune pathways trigger Autoimmune hepatitis( AIH)\& lead to its progression .Apoptosis of intestinal epithelial cells in response to microbial stimuli presentation of self-antigens leading to differentiation of autoreactive Th17 cells and other T helper cells leading to T-cell response of AILD.(1). Disease-associated dysbiosis in untreated patients with AIH was characterised by reduced biodiversity, decreased abundance of anaerobes and increase of the genera Veillonella, Klebsiella, Streptococcus and Lactobacillus(2-3).It remains unclear whether this microbial signature is specific compared to other autoimmune liver diseases or other immune-mediated diseases, and whether it is reproducible across geographic borders .However there is Scarce paediatric data comparing gut microbiota in AILD vs other liver diseases and no data on role of gut microbiota on response to treatment in AILD .
The aim of this study will be to To compare the gut microbiota (dysbiosis ratio, alpha and beta diversity, Shannon index) in children with autoimmune liver disease and Wilson disease, and study its influence on response to treatment in children with autoimmune liver disease.
Read the detailed description
Aim and Objective - To compare the gut microbiota (dysbiosis ratio, alpha and beta diversity, Shannon index) in children with autoimmune liver disease versus those with Wilson disease, and study its influence on response to treatment in children with autoimmune liver disease.
(b) Methodology:
- Study population:Disease cohort: Children with evidence of chronic liver disease with autoimmune Liver disease and Wilson disease (hepatic involvement) under 18 years of age
- Control cohort: Agematched healthy children under-18-year age with Study design:Prospective observational study
- Study period:From the time of Ethical approval to June 2025
Stool for 16S r-RNA sequencing: Fresh stool samples will be collected from study subjects and controls. Stool samples will be delivered to the laboratory in sterile plastic containers at 4°C, and stored at -80°C till further analysis .The amplified DNA will be sequenced in the next generation sequencing platform. Sequence data would be processed using standardized analysis pipeline. Briefly, sequences would be joined, depleted of barcodes, sequences <150bp and those with ambiguous base calls would be removed. Sequences would be denoised, operational taxonomic units (OTUs) generated and chimeras removedThe intestinal microbiome will be studied by whole genome shotgun metagenomic sequencing (WGSM).By detection of bacterial genes for metabolic digestive enzymes of taxa present, metabolic capacities and potential production of metabolites by the gut microbiome will be predicted.Sequences would be denoised, operational taxonomic units (OTUs) generated and chimeras removed .The intestinal microbiome will be studied by whole genome shotgun metagenomic sequencing (WGSM) .By detection of bacterial genes for metabolic digestive enzymes of taxa present, metabolic capacities and potential production of metabolites by the gut microbiome will be predicted.
- Monitoring and assessment:Children with evidence of chronic liver disease with autoimmune Liver disease and Wilson disease (hepatic involvement) will be included Control cohort: Age, gender and socio-economic status matched healthy children under-18-year age with TNF-alpha , IL-6,Plasma endotoxin , CRP, Procalcitonin, Duodenal aspirate for culture to identify bacterial overgrowth . Stool samples will be collected at baseline in Patients with AILD , Wilson and Healthy controls .AILD patients will be started On treatment with Prednisolone 1 mg/kg/day along with Azathioprine 1 mg/kg/day and Stool samples of them will be collected at the end yo see the response to immunosuppression Difficult to treat AILD (which will be defined Failure to normalize AST/ALT within 1.5 times or failure to normalize IgG within 6 months. )
STATISTICAL ANALYSIS:
- The categorical and continuous variables will be expressed as frequencies and mean or median ±SD, respectively. Chi-square test and student's t-test (Fisher's exact test) will be applied for assessment of causality. Correlation between 2 continuous variables will be assessed as per Spearman's correlation. Statistical significance will be mentioned as p-value <0.05, and Odd's ratio and 95% confidence intervals (95% CI). For metagenomic data, in the absence of gene catalogue for the study population, we will study the metagenomic data in first 10 AILD, 5 Wilson and 5 controls ,].
- Conditions
- Autoimmune Diseases
- Being tested
- No intervention
- Medical subject headings
- Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Autoimmune Liver Disease | Autoimmune Liver Disease Receives: Other: No intervention | |
| Wilsons Disease | Wilsons Disease Receives: Other: No intervention | |
| Healthy Control | Healthy Control Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the gut microbiota in children with autoimmune Liver disease and those with Wilson disease and age matched healthy controls.
Measured: Day 0 & 6 months
Secondary outcomes (3)
Inflammatory markers (TNF-alpha, IL-6)
Measured: Day 0
Markers of bacterial infection (Plasma endotoxin, CRP, Procalcitonin)
Measured: Day 0
Gut microbiota in children with AILD with easy to treat versus difficult to treat AIH (persistent elevation of AST & ALT above 1.5 times upper limit of normal at 6 months of initiation of treatment)
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start1 Nov 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune DiseasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
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
- NCT06183190
- Sponsor's protocol ID
- ILBS-AIH-01
- Status last verified
- Dec 2023
- First submitted
- 13 Dec 2023
- Last updated
- 9 Jul 2025
- 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 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Microbiota In Children With Autoimmune Liver Disease and Its Effect on Treatment Response
- ClinicalTrials.gov ID
- NCT06183190
- Acronym / sponsor ID
- ILBS-AIH-01
- Conditions
- Autoimmune Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 27 Dec 2023 (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.
Gut microbiota and liver disease are very closely linked. Microbiota influences the various liver diseases by Dysbiosis ratio .There is loss of tolerance targeting liver antigens which is thought to initiate disease in genetically susceptible individuals. This is triggered by environmental agents such as pathogens.Autoimmune Liveer disease(AILD )patients have Specific bacterial profile and Alterations in bacterial metabolites and immune pathways trigger Autoimmune hepatitis( AIH)\& lead to its progression .Apoptosis of intestinal epithelial cells in response to microbial stimuli presentation of self-antigens leading to differentiation of autoreactive Th17 cells and other T helper cells leading to T-cell response of AILD.(1). Disease-associated dysbiosis in untreated patients with AIH was characterised by reduced biodiversity, decreased abundance of anaerobes and increase of the genera Veillonella, Klebsiella, Streptococcus and Lactobacillus(2-3).It remains unclear whether this microbial signature is specific compared to other autoimmune liver diseases or other immune-mediated diseases, and whether it is reproducible across geographic borders .However there is Scarce paediatric data comparing gut microbiota in AILD vs other liver diseases and no data on role of gut microbiota on response to treatment in AILD .
The aim of this study will be to To compare the gut microbiota (dysbiosis ratio, alpha and beta diversity, Shannon index) in children with autoimmune liver disease and Wilson disease, and study its influence on response to treatment in children with autoimmune liver disease.
Detailed description
Aim and Objective - To compare the gut microbiota (dysbiosis ratio, alpha and beta diversity, Shannon index) in children with autoimmune liver disease versus those with Wilson disease, and study its influence on response to treatment in children with autoimmune liver disease.
(b) Methodology:
- Study population:Disease cohort: Children with evidence of chronic liver disease with autoimmune Liver disease and Wilson disease (hepatic involvement) under 18 years of age
- Control cohort: Agematched healthy children under-18-year age with Study design:Prospective observational study
- Study period:From the time of Ethical approval to June 2025
Stool for 16S r-RNA sequencing: Fresh stool samples will be collected from study subjects and controls. Stool samples will be delivered to the laboratory in sterile plastic containers at 4°C, and stored at -80°C till further analysis .The amplified DNA will be sequenced in the next generation sequencing platform. Sequence data would be processed using standardized analysis pipeline. Briefly, sequences would be joined, depleted of barcodes, sequences <150bp and those with ambiguous base calls would be removed. Sequences would be denoised, operational taxonomic units (OTUs) generated and chimeras removedThe intestinal microbiome will be studied by whole genome shotgun metagenomic sequencing (WGSM).By detection of bacterial genes for metabolic digestive enzymes of taxa present, metabolic capacities and potential production of metabolites by the gut microbiome will be predicted.Sequences would be denoised, operational taxonomic units (OTUs) generated and chimeras removed .The intestinal microbiome will be studied by whole genome shotgun metagenomic sequencing (WGSM) .By detection of bacterial genes for metabolic digestive enzymes of taxa present, metabolic capacities and potential production of metabolites by the gut microbiome will be predicted.
- Monitoring and assessment:Children with evidence of chronic liver disease with autoimmune Liver disease and Wilson disease (hepatic involvement) will be included Control cohort: Age, gender and socio-economic status matched healthy children under-18-year age with TNF-alpha , IL-6,Plasma endotoxin , CRP, Procalcitonin, Duodenal aspirate for culture to identify bacterial overgrowth . Stool samples will be collected at baseline in Patients with AILD , Wilson and Healthy controls .AILD patients will be started On treatment with Prednisolone 1 mg/kg/day along with Azathioprine 1 mg/kg/day and Stool samples of them will be collected at the end yo see the response to immunosuppression Difficult to treat AILD (which will be defined Failure to normalize AST/ALT within 1.5 times or failure to normalize IgG within 6 months. )
STATISTICAL ANALYSIS:
- The categorical and continuous variables will be expressed as frequencies and mean or median ±SD, respectively. Chi-square test and student's t-test (Fisher's exact test) will be applied for assessment of causality. Correlation between 2 continuous variables will be assessed as per Spearman's correlation. Statistical significance will be mentioned as p-value <0.05, and Odd's ratio and 95% confidence intervals (95% CI). For metagenomic data, in the absence of gene catalogue for the study population, we will study the metagenomic data in first 10 AILD, 5 Wilson and 5 controls ,].
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Autoimmune Liver Disease | – | Other: No interventionAutoimmune Liver Disease |
| Wilsons Disease | – | Other: No interventionWilsons Disease |
| Healthy Control | – | Other: No interventionHealthy Control |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- * Study population:Disease cohort: Children with evidence of chronic liver disease with autoimmune Liver disease and Wilson disease (hepatic involvement) under 18 years of age * Control cohort: Agematched healthy children under-18-year age with
Key inclusion criteria (4 listed)
- Disease cohort: Children with evidence of chronic liver disease with autoimmune Liver disease and Wilson disease (hepatic involvement).
- Control cohort: Age and socio-economic status matched healthy children under-18-year age with
- Wilson disease: Diagnosis as per AASLD guidelines i.e. presence of either 3 of the following: Kayser Fleischer ring in cornea, 24-hour urine copper >40 microgm /day, serum ceruloplasmin <20 mg/dL; Leipzig score >4 or presence of one homozygous or 2 or more compound heterozygous disease causing mutations in ATP7B gene.
- Autoimmune liver disease: Diagnosis on the basis of presence of abnormalities in transaminases with hypergammaglobinemia, positive autoantibodies (anti-nuclear, anti-smooth muscle, anti-liver-kidney-microsomal, anti-soluble liver antigen), suggestive liver biopsy (interface hepatitis, plasma cell infiltrates, emperipolesis, pseudorosettes) in absence of other known causes of liver disease (viral hepatitis, Wilson disease, Budd-Chiari syndrome, etc) and simplified score ≥ 6
Key exclusion criteria (8 listed)
- Antibiotic usage for last 1 week or immunosuppression usage for last 4 weeks
- Liver tumours
- Active or recent episode of gastroenteritis within 1 week of presentation
- Diabetes mellitus
- Primary and secondary immunodeficiency states (HIV)
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 |
|---|---|---|
| No interventionNo intervention | Other | Autoimmune Liver Disease, Healthy Control, Wilsons Disease |
Primary outcome
To compare the gut microbiota in children with autoimmune Liver disease and those with Wilson disease and age matched healthy controls.
Time frame: Day 0 & 6 months
3 secondary outcomes
Inflammatory markers (TNF-alpha, IL-6)
Time frame: Day 0
Markers of bacterial infection (Plasma endotoxin, CRP, Procalcitonin)
Time frame: Day 0
Gut microbiota in children with AILD with easy to treat versus difficult to treat AIH (persistent elevation of AST & ALT above 1.5 times upper limit of normal at 6 months of initiation of treatment)
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Diseases, 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 9 Jul 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the gut microbiota in children with autoimmune Liver disease and those with Wilson disease and age matched healthy controls. (time frame: Day 0 & 6 months). 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 9 Jul 2025.