Registry for children with Non-Alcoholic Fatty Liver Disease in Europe

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The EU-PNAFLD is a collaborative network of European centers focused on the care of children diagnosed with Non-Alcoholic Fatty Liver Disease (NAFLD). This observational registry aims to create a large-scale cohort that will facilitate multi-center clinical trials and enhance understanding of the disease mechanisms and natural history of pediatric NAFLD. It will leverage existing databases and bio-repositories while aligning with the adult European NAFLD Registry for comprehensive long-term follow-up. The collaboration includes hepatologists, endocrinologists, and scientists, supported by international specialists.

Why it matters

Who can join: the full rules

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

Where it's running

• Addenbrooke's Hospital
  Cambridge, Cambridgeshire, United Kingdom Recruiting
• Birmingham Children's Hospital
  Birmingham, United Kingdom Recruiting
• Maastricht UMC
  Maastricht, Netherlands Active not recruiting

Study contacts

• Principal investigator: David B Savage — University of Cambridge
• Study coordinator: Jake P Mann, MRCPCH
• Email: jm2032@cam.ac.uk
• Phone: 0044124644

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.