Prevalence of Non-Alcoholic Fatty Liver Disease in Inflammatory Bowel Disease Patients
Observational · No treatment assigned · 1 site · Centre Hospitalier Universitaire Saint Pierre
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: NAFLD, Inflammatory Bowel Diseases and Steatosis. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- Diagnosis of IBD based on clinical, endoscopic, and histological gounds according to the latest ECCO guidelines
- Willingness to provide informed consent for study participation
There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 150 participants are expected to take part.
- Start date: 2024-11-01.
- Main results expected around 2025-10-01 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Belgium.
Main thing being measured
- Prevalence of NAFLD in the population of IBD patients followed at the University Hospital IBD clinic. (From enrollement to the end of the study, up to 12 months)
In the researchers’ words
Non-alcoholic Fatty Liver Disease (NAFLD) refers to a spectrum of disease characterized by the presence of more than 5% of steatosis in hepatocytes of individuals who consume little or no alcohol. It ranges from simple steatosis without evidence of inflammation, to the association of steatosis and inflammation with cellular necrosis, the so-called non-alcoholic steatohepatitis (NASH).
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | NAFLD; Inflammatory Bowel Diseases; Steatosis; Fibrosis, Liver |
| Lead sponsor | Centre Hospitalier Universitaire Saint Pierre |
| Enrollment | 150 (estimated) |
| Start date | 2024-11-01 |
| Primary completion (est.) | 2025-10-01 |
| First posted | 2025-02-07 |
| Last updated | 2025-02-07 |
| Official title | Prevalence of Non-Alcoholic Fatty Liver Disease in Inflammatory Bowel Disease Patients: A Prospective Monocentric Study |
| ClinicalTrials.gov ID | NCT06814600 |
Interventions
- Transient elastometry (Diagnostic Test)
Controlled attenuation parameter (CAP) and liver stiffness measurement (LSM) will be measured by transient liver elastometry "Fibroscan" to evaluate hepatic steatosis and fibrosis in all patients at baseline. Absence of steatosis S0 is defined as CAP <248 dB/m, mild steatosis S1 with CAP < 268 dB/m, and moderate to severe steatosis ≥ S2 is defined as CAP >280 dB/m. Liver fibrosis will be evaluated…
Full eligibility criteria (from the record)
Inclusion Criteria: * Diagnosis of IBD based on clinical, endoscopic, and histological gounds according to the latest ECCO guidelines * Willingness to provide informed consent for study participation Exclusion Criteria: * Presence of established liver disease (including autoimmune hepatitis, primary biliary cholangitis, primary biliary cirrhosis, hemochromatosis, Wilson's disease, positive serology for viral hepatitis B or C) * History of hepatocellular carcinoma or liver transplantation * History of excessive alcohol consumption defined as >3 units per day for women and > 5 units per day for men * Pregnancy at the time of recruitment * Failure to perform an elastography mesure or missing elastography data
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Saint Pierre | Brussels | Belgium | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.