The Gut-Liver-Axis in paediatric hepatology – examining changes in the gut microbiome and their role for the progression of paediatric liver disease before and after paediatric liver transplantatio

Recruiting

Conditions: Q44.2
Z94.4
Atresia of bile ducts
Liver transplant status

Registration Number: DRKS00027089

Lead Sponsor: Medizinische Hochschule Hannover

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 100

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

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

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Part 1: Primary outcome for part 1 is the difference in gut microbiota alpha- diversity and composition between children with different etiologies for neonatal cholestasis (biliary atresia vs other etiologies) and healthy children.. <br>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 Outcome Measures

Name	Time	Method
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.<br><br>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.