NAFLDPONINCT06814600
Prevalence of Non-Alcoholic Fatty Liver Disease in Inflammatory Bowel Disease Patients
An observational study of NAFLD and Inflammatory Bowel Diseases, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NAFLD, Inflammatory Bowel Diseases, Steatosis
- What is being tested?
- Transient elastometry
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Nov 2024to 1 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: IBD patients followed at Saint-Pierre University Medical Center, Brussels, Belgium
Who may be able to join
- Diagnosis of IBD based on clinical, endoscopic, and histological gounds according to the latest ECCO guidelines
- Willingness to provide informed consent for study participation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
CHU Saint Pierre
Brussels, 1000
Jennifer Aoun, Medical doctor, +32 25353296, jennifer.aoun@stpierre-bru.be
Vinciane Muls, Medical doctor, +32 25354455, vinciane.muls@stpierre-bru.be
About this study
Official title: Prevalence of Non-Alcoholic Fatty Liver Disease in Inflammatory Bowel Disease Patients: A Prospective Monocentric Study
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). NAFLD has become increasingly common in developed countries affecting up to 38% of the population. It is mostly but not exclusively associated with metabolic syndrome including obesity, insulin resistance, and hypertension. There is growing evidence of a close interaction between the gut and the liver "Gut-liver axis", particularly in the pathogenesis of NAFLD. The pathophysiological mechanism behind this association is not well understood but involves small intestinal bacterial overgrowth (SIBO), intestinal wall inflammation and increased permeability, all leading to systemic translocation of microbial metabolites including endotoxins and pro-inflammatory markers called Pathogen Associated Molecular Pattern (PAMPs). Thus, the gut-liver interaction, mediated by cytokines and inflammatory proteins seem to be the cornerstone of this complex liver disease.
Recent studies underlined the increased prevalence of NAFLD in the Inflammatory Bowel Disease (IBD) population, accounting for almost 32% of hepatic extra-intestinal manifestations of the disease. Several hypotheses have been proposed to explain the pathophysiology behind this association, encompassing chronic intestinal wall inflammation, increased intestinal permeability and altered gut microbiota or dysbiosis. To our knowledge, no studies have been conducted so far to investigate the correlation between intestinal disease activity (IBD flare versus remission state) and NAFLD incidence and behavior (progression versus regression of steato-fibrosis). We therefore aim to conduct a prospective paired study, on IBD patients followed at Saint-Pierre University Hospital, aiming to explore this correlation.
In this paired study design, patients will be their own controls over the course of their disease: An evaluation of NAFLD will be done for all patients during both phases of their inflammatory bowel disease: In the active phase and in remission phase. Our primary outcome is to assess NAFLD prevalence in the IBD population followed at our institution. Secondary outcomes will be to explore NAFLD prevalence and behavior (progression versus regression of steato-fibrosis) according to IBD activity, IBD type, IBD duration and types of IBD treatments.
- Conditions
- NAFLD, Inflammatory Bowel Diseases, Steatosis, Fibrosis, Liver
- Being tested
- Transient elastometry
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Inflammatory Bowel Diseases, Fatty Liver, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transient elastometryDiagnostic 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 using the liver stiffness measurement (LSM) in kPa7.
| Study group | Role | What they receive |
|---|---|---|
| Baseline assessment | All patients with a confirmed diagnosis of IBD (cf. inclusion criteria) will have their demographic and clinical data collected during consultation via the medical record system Xcare/Abrumet. This include their age, gender, ethnicity, calculated BMI, alcohol consumption, smoking history, medical history (Hypertension, diabetes type II and dyslipidemia) and surgical history.
Clinical data such as disease type, duration and IBD related current medications will be noted. The gastroenterologist will fill an assessment questionnaire in order to clinically assess the disease activity. This consists of Partial Mayo clinical score (pMayo) for Ulcerative Colitis and Harvey Bradshaw Index (HBI) for Crohn's disease. Remission is defined as a pMayo ≤ 1 or a HBI <5, mild disease is defined as pMayo between 2 and 4, or HBI between 5 and 7. Finally, moderate to severe disease is defined as pMayo ≥ 5, or HBI > 85.
According to the data provided, patients will be classified into two sub-groups accor Receives: Diagnostic Test: Transient elastometry | |
| Follow-up Assessment | Patients selected in the phase A of the study will be followed over time, through the course of their disease following the usual protocol for IBD patients follow up.
They will undergo the same assessment when a change in the baseline intestinal disease activity occurs: This is defined as a progression from remission state to active disease state or vice versa.
The assessment consists of the clinical questionnaire to be filled by the gastroenterologist during a follow up consultation (pMayo and HBI), routine blood tests for biochemical follow up of the disease activity, measurements of cytokines and inflammatory proteins (similar to phase A), FIB-4 score calculation and a repeat transient elastometry "Fibroscan". Receives: Diagnostic Test: Transient elastometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of NAFLD in the population of IBD patients followed at the University Hospital IBD clinic.
Prevalence of NAFLD in the population of IBD patients followed at the University Hospital IBD clinic.
Measured: From enrollement to the end of the study, up to 12 months
Secondary outcomes (2)
Behavior of NAFLD according to the IBD activity
Behavior of NAFLD (progression versus regression of steato-fibrosis) according to IBD activity (active disease versus remission)
Measured: From enrollement to the end of the study, up to 12 months
NAFLD predictors in IBD patients
Independent predictors (risk factors) for NAFLD in our IBD patients study population such as particular demographics, IBD disease type, IBD disease duration, IBD treatments, patients' immunological profiles, and various inflammatory markers.
Measured: From enrollement to the end of the study, up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start1 Nov 2024
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Aoun, Centre Hospitalier Universitaire Saint Pierre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06814600
- Sponsor's protocol ID
- PONI
- Acronym
- PONI
- Status last verified
- Jan 2025
- First submitted
- 30 Jan 2025
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Non-Alcoholic Fatty Liver Disease in Inflammatory Bowel Disease Patients: A Prospective Monocentric Study
- ClinicalTrials.gov ID
- NCT06814600
- Acronym / sponsor ID
- PONI / PONI
- Conditions
- NAFLD, Inflammatory Bowel Diseases, Steatosis, Fibrosis, Liver
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 7 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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). NAFLD has become increasingly common in developed countries affecting up to 38% of the population. It is mostly but not exclusively associated with metabolic syndrome including obesity, insulin resistance, and hypertension. There is growing evidence of a close interaction between the gut and the liver "Gut-liver axis", particularly in the pathogenesis of NAFLD. The pathophysiological mechanism behind this association is not well understood but involves small intestinal bacterial overgrowth (SIBO), intestinal wall inflammation and increased permeability, all leading to systemic translocation of microbial metabolites including endotoxins and pro-inflammatory markers called Pathogen Associated Molecular Pattern (PAMPs). Thus, the gut-liver interaction, mediated by cytokines and inflammatory proteins seem to be the cornerstone of this complex liver disease.
Recent studies underlined the increased prevalence of NAFLD in the Inflammatory Bowel Disease (IBD) population, accounting for almost 32% of hepatic extra-intestinal manifestations of the disease. Several hypotheses have been proposed to explain the pathophysiology behind this association, encompassing chronic intestinal wall inflammation, increased intestinal permeability and altered gut microbiota or dysbiosis. To our knowledge, no studies have been conducted so far to investigate the correlation between intestinal disease activity (IBD flare versus remission state) and NAFLD incidence and behavior (progression versus regression of steato-fibrosis). We therefore aim to conduct a prospective paired study, on IBD patients followed at Saint-Pierre University Hospital, aiming to explore this correlation.
In this paired study design, patients will be their own controls over the course of their disease: An evaluation of NAFLD will be done for all patients during both phases of their inflammatory bowel disease: In the active phase and in remission phase. Our primary outcome is to assess NAFLD prevalence in the IBD population followed at our institution. Secondary outcomes will be to explore NAFLD prevalence and behavior (progression versus regression of steato-fibrosis) according to IBD activity, IBD type, IBD duration and types of IBD treatments.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baseline assessment | – | Diagnostic Test: Transient elastometryAll patients with a confirmed diagnosis of IBD (cf. inclusion criteria) will have their demographic and clinical data collected during consultation via the medical record system Xcare/Abrumet. This include their age, gender, ethnicity, calculated BMI, alcohol consumption, smoking history, medical history (Hypertension, diabetes type II and dyslipidemia) and surgical history. Clinical data such as disease type, duration and IBD related current medications will be noted. The gastroenterologist will fill an assessment questionnaire in order to clinically assess the disease activity. This consists of Partial Mayo clinical score (pMayo) for Ulcerative Colitis and Harvey Bradshaw Index (HBI) for Crohn's disease. Remission is defined as a pMayo ≤ 1 or a HBI <5, mild disease is defined as pMayo between 2 and 4, or HBI between 5 and 7. Finally, moderate to severe disease is defined as pMayo ≥ 5, or HBI > 85. According to the data provided, patients will be classified into two sub-groups accor |
| Follow-up Assessment | – | Diagnostic Test: Transient elastometryPatients selected in the phase A of the study will be followed over time, through the course of their disease following the usual protocol for IBD patients follow up. They will undergo the same assessment when a change in the baseline intestinal disease activity occurs: This is defined as a progression from remission state to active disease state or vice versa. The assessment consists of the clinical questionnaire to be filled by the gastroenterologist during a follow up consultation (pMayo and HBI), routine blood tests for biochemical follow up of the disease activity, measurements of cytokines and inflammatory proteins (similar to phase A), FIB-4 score calculation and a repeat transient elastometry "Fibroscan". |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- IBD patients followed at Saint-Pierre University Medical Center, Brussels, Belgium
Key inclusion criteria (2 listed)
- Diagnosis of IBD based on clinical, endoscopic, and histological gounds according to the latest ECCO guidelines
- Willingness to provide informed consent for study participation
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transient elastometryControlled 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 using the liver stiffness measurement (LSM) in kPa7. | Diagnostic test | Baseline assessment, Follow-up Assessment |
Primary outcome
Prevalence of NAFLD in the population of IBD patients followed at the University Hospital IBD clinic.
Time frame: From enrollement to the end of the study, up to 12 months
Prevalence of NAFLD in the population of IBD patients followed at the University Hospital IBD clinic.
2 secondary outcomes
Behavior of NAFLD according to the IBD activity
Time frame: From enrollement to the end of the study, up to 12 months
NAFLD predictors in IBD patients
Time frame: From enrollement to the end of the study, up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NAFLD and Inflammatory Bowel Diseases, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Aoun, Medical Doctor (+3225353296, jennifer.aoun@stpierre-bru.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of NAFLD in the population of IBD patients followed at the University Hospital IBD clinic. (time frame: From enrollement to the end of the study, up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.