About this trial
The EU-PNAFLD (The European Paediatric NALFD Registry) will be a network composed of European centres involved in the care of children with NAFLD, and will include Hepatologists, Endocrinologists, and Scientists, supported by relevant international specialists. This collaboration will build on existing infrastructure (local databases and bio-repositories) and will align with the adult European NAFLD Registry ("EPoS", Elucidating Pathways of Steatohepatitis study) to allow long-term follow-up supported by translational studies. Through an international, well-characterised large-scale cohort, we hope to: facilitate multi-centre clinical trials; extend our understanding of the key disease mechanisms of NAFLD; and establish the natural history of paediatric NAFLD.
Eligibility criteria
Qualifiers
Diagnosis made under 18 years of age.
Diagnosis of NAFLD spectrum disease (simple steatosis (NAFL), steatosis with abnormal transaminases, NASH ± fibrosis or cirrhosis)
Radiological evidence of hepatic steatosis (e.g. increased hepatic echogenicity on ultrasound), with
Exclusion of secondary causes (negative serological liver screen for HBV/HCV, caeruloplasmin >0.20g/L, no history of excess alcohol consumption, no evidence of iron overload, and no clinically significant alpha-1 antitrypsin (A1AT) phenotype (i.e. SZ, ZZ, SS), with or without
Disqualifiers
Secondary fatty liver disease (e.g. glycogen storage diseases, Wilson disease, viral hepatitis, drug-related, autoimmune hepatitis, type 1 diabetes mellitus)
Post-transplant fatty liver
>20g/day ethanol intake
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Sponsors and collaborators
Cambridge University Hospitals NHS Foundation Trust
Lead sponsor
The European Association for the Study of the Liver
Collaborator
Children's Liver Disease Foundation
Collaborator