Q44.2 Z94.4
Conditions
Interventions
Group 1: Infants with cholestatic liver disease will undergo fecal sampling for gut microbiota analysis at the time of diagnosis and at regular intervals up to the age of 12 months. In addition, paren
Sponsors
Medizinische Hochschule Hannover
Eligibility
Sex/Gender
All
Age
1 Months to 18 Years
Inclusion criteria
Inclusion criteria: Part I: Inclusion: Patients: Children 0-12 months of any sex with a presentation of "neonatal cholestasis" and/or confirmed diagnosis of biliary atresia, informed consent by parents/legal gurdians. Controls: Infants aged 0-5 months, without known systemic disease and without acute infectious disease, possibly with phimosis or inguinal hernia. Part II: Inclusion: children 0-18 years of any sex who receive or have already undergone liver transplants during the study period; informed consent by parents/legal gurdians
Exclusion criteria
Exclusion criteria: Part 1. Exclusion: Defined chronic inflammatory or structural disease of the intestine such as microvillous inclusion disease, surgical short bowel, congenital diarrhea, very early onset inflammatory bowel disease (VEO-IBD), lack of study consent. For healthy controls: A history of antibiotic therapy within 4 weeks prior to inclusion Part 2: Exclusion: Defined chronic inflammatory or structural disease of the intestine such as Crohn's disease, ulcerative colitis, microvillous inclusion disease, surgical short bowel, lack of study consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: Primary outcome for part 1 is the difference in gut microbiota (GM) alpha- diversity and composition between children with different etiologies for neonatal cholestasis (biliary atresia vs other etiologies) and healthy children. Part 2: Primary outcome for part 2 is the characterization of the GM composition in children with terminal liver disease (alpha-diversity, composition) based on etiology and morbidity. | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1: secondary outcome is GM beta diversity (changes in diversity) over time in children with neonatal cholestasis in relation to the clinical outcome. Clinical outcome include complications and native liver survival. Clinical impact variables include diet and antibiotic therapy. Part 2: secondary outcome for part 2 is intra-individual GM beta diversity over time in relation to clinical outcome, namely occurrence of rejection and infections. Part II b looks at alpha diversity in long-term transplant follow-up and a possible association with graft fibrosis measured by ISHAK and LAF score. | — |
Countries
Germany
Contacts
Public ContactImeke Goldschmidt
Medizinische Hochschule Hannover
Outcome results
None listed