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

NHS Foundation Trust

Status

Enrolling

Conditions

Non-alcoholic Steatohepatitis

Non-Alcoholic Fatty Liver Disease

Non-alcoholic Fatty Liver

Study type

Observational

Funder types

Other

Identifiers

NCT04190849

A094204

174534

Details and patient eligibility

About

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.

Enrollment

2,000 estimated patients

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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