K75.4
Conditions
Interventions
Group 1: Study population (patients with autoimmune hepatitis): Concurrent sigmoidoscopy with sample collection, as well as analysis of blood and stool samples at the time of liver biopsy at diagnosis
Sponsors
Universitätsklinikum Hamburg Eppendorf
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: AIH-Group - Suspected (based on laboratory criteria) or confirmed diagnosis of autoimmune hepatitis - Clinical indication for liver biopsy - Written informed consent for participation in the study
Exclusion criteria
Exclusion criteria: AIH-Group: - Concomitant presence of PSC or PBC (so-called overlap syndrome), liver cirrhosis, other chronic liver diseases, or inflammatory bowel disease (IBD) - Other severe comorbidities that may affect the microbiome or immune system - Additional immunosuppressive therapy due to another comorbidity - At the time of biopsy: presence of a bacterial infection requiring antibiotic treatment - Antibiotic therapy within the previous 4 weeks - Intake of probiotics within the previous 2 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composition and diversity of the mucosal microbiome in patients with AIH at the time of diagnosis of AIH | — |
Secondary
| Measure | Time frame |
|---|---|
| - Association between the mucosal microbiome and treatment response after 6 months - Longitudinal changes in the mucosal microbiome under immunosuppressive therapy - Association between the mucosal microbiome and the occurrence of relapses - Association of the mucosal microbiome with intestinal barrier function, and potential changes in immune cell composition or endothelial cells within the liver - Differences between the mucosal microbiome and the luminal microbiome - Association of microbial metabolites with inflammatory activity in the liver | — |
Countries
Germany
Contacts
Public ContactKatharina Moll
Universitätsklinikum Hamburg Eppendorf
Outcome results
None listed