At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Not specified by the sponsor
- How long the study runs
- Study runs about 360 months (dates as stated)
- About the drug or intervention
- Not specified by the sponsor
- Patient visit burden
- Not specified by the sponsor
In plain English
This is a European registry for children and young people who were diagnosed with non-alcoholic fatty liver disease (NAFLD) — a build-up of fat in the liver — before the age of 18. It also covers non-alcoholic steatohepatitis (NASH), a more serious form where the liver becomes inflamed or scarred. It is run by Cambridge University Hospitals NHS Foundation Trust.
Who can take part
- Diagnosed with NAFLD (or NASH, with or without scarring) before the age of 18
- Diagnosis shown by a scan (such as an ultrasound) that found fat in the liver
- Other causes of liver problems have been ruled out with blood tests, and there is no history of drinking too much alcohol, iron overload, or certain alpha-1 antitrypsin (a liver protein) problems
- In some cases, the diagnosis may also be confirmed with a small sample of liver tissue (a biopsy)
Who may not be able to
- Fatty liver caused by another condition, such as Wilson disease, viral hepatitis, autoimmune hepatitis, type 1 diabetes, glycogen storage diseases, or medicines
- Fatty liver that developed after a liver transplant
- Drinking more than 20 grams of alcohol a day
What taking part involves
- • Not stated — ask the trial team. This is a registry, so it collects information rather than giving a treatment.
Time commitment: Not stated — ask the trial team about how many visits are needed, how long it lasts, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Observing health over time
- Ages
- Up to 18 Years
- Who
- All
- Number of participants
- 2,000
- Started
- 2017-11-14
- Last checked
- 2022-02
Plain English Summary
What is this study?
- • Testing a new treatment for non-alcoholic fatty liver disease
- • Clinical study - 2,000 participants
- • 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
Who can take part?
- • Ages Up to 18 Years
- • Diagnosed with non-alcoholic fatty liver disease
Where?
- • Cambridge - Addenbrooke's Hospital
- • Birmingham - Birmingham Children's Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: Up to 18 Years
- Who can join: All genders
What the study is looking for
- ✓Diagnosis made under 18 years of age.
- ✓Diagnosis of NAFLD spectrum disease (simple steatosis (NAFL), steatosis with abnormal transaminases, NASH ± fibrosis...
- ✓Diagnosis established by:
- ✓Radiological evidence of liver steatosis (e.g. increased liver echogenicity on ultrasound), with
- ✓Histology (\>5% steatosis and histology consistent with paediatric NAFLD)
Who cannot take part
- ✗Secondary fatty liver disease (e.g. glycogen storage diseases, Wilson disease, viral hepatitis, drug-related,...
- ✗Post-transplant fatty liver
- ✗\>20g/day ethanol intake
See the full criteria
Where Is This Study? (2 UK sites)
Addenbrooke's Hospital
Cambridge CB2 0QQ, United Kingdom
Birmingham Children's Hospital
Birmingham, United Kingdom
How to Get in Touch
Jake P Mann, MRCPCH
Sponsor contactCONTACT