RecruitingNCT04190849

European Paediatric Non-Alcoholic Fatty Liver Disease Registry (EU-PNAFLD)

The European Paediatric Non-alcoholic Fatty Liver Disease Registry (EU-PNAFLD): a Prospective, Longitudinal Follow-up of Children With Non-alcoholic Fatty Liver Disease

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Enrollment

2,000 participants

Start Date

Nov 14, 2017

Study Type

OBSERVATIONAL

Conditions

Non-Alcoholic Fatty Liver Disease Non Alcoholic Steatohepatitis Non-alcoholic Fatty Liver

Summary

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

Max Age: 18 Years

Inclusion Criteria6

Diagnosis made under 18 years of age.
Diagnosis of NAFLD spectrum disease (simple steatosis (NAFL), steatosis with abnormal transaminases, NASH ± fibrosis or cirrhosis)
Diagnosis established by:
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
Histology (\>5% steatosis and histology consistent with paediatric NAFLD)

Exclusion Criteria3

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