Inflammatory Bowel Disease, Crohn’s Disease, Ulcerative Colitis Inflammatory Bowel Disease, IBD, Crohn's Disease, Ulcerative Colitis
Conditions
Interventions
No intervention
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: To be eligible for participating in this study, subjects must meet the following criteria in general:Age between 18 and 65 years and capacity to exercise free will;Written informed consent provided.Additional criteria for subjects with IBD: Diagnosis of IBD (Crohn’s disease [CD], ulcerative colitis [UC], or IBD-unclassified [IBD-U]) for at least 1 year, confirmed by internationally accepted criteria combining clinical, endoscopic, histologic, and radiologic assessments;Clinically quiescent IBD, with a Harvey Bradshaw Index (HBI) < 5 for CD and a Simple Clinical Colitis Activity Index (SCCAI) = 2 for UC or IBD-U;Faecal calprotectin <150 µg/g, indicating clinically quiescent IBD;Stable medication regimen for at least 3 months prior to inclusion;For Cohort 1: Presence of chronic severe fatigue, defined as an inflammatory bowel disease fatigue scale (IBD-F) score = 11, persisting for at least 3 months For Cohort 2: Absence of fatigue, defined as a IBD-F score = 7.5Additional criteria for healthy subjects: Age-matched (and preferably sex-matched) to the IBD patient group;No history of IBD;No history of neurological or psychiatric disorders or (treated) cancer that may cause fatigue or depression;Normal inflammatory markers in a blood sample taken within the past 2 weeks, i.e. levels of CRP < 10.;Faeces calprotectin < 150 µg/g;Absence of fatigue, defined as a Fatigue Severity Scale (FSS) score of < 4.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study:The presence of claustrophobia;MRI-specific exclusion criteria, such as metallic implants– screening for these exclusion criteria will be done using the regular 7T MRI safety questionnaire;Known allergies or hypersensitivity to gadolinium-based contrast agents;Impaired renal function (severe renal insufficiency, GFR < 30ml/min/1,73m2; or nephrogenic systemic fibrosis / nephrogenic fibrosing nephropathy (NSF/NFD));Significant comorbidities affecting neurological or cognitive function, including previous stroke, neurodegenerative diseases, or significant psychiatric disorders;Untreated diagnosis of other causes of fatigue, including thyroid dysfunction, liver or renal failure, anaemia, folate-, iron-, vitamin B12- or D deficiency;Comorbidities that are known to be associated with fatigue, such as primary sclerosing cholangitis, heart failure, chronic obstructive pulmonary disease, active or treated malignancy, and any chronic systemic inflammatory disease unrelated to IBD;History of head trauma or brain surgery; Pregnancy or breastfeeding; Infectious illness, either at moment of study start or < 4 weeks before (fever >38.4 degrees Celsius and/or flu) or vaccination < 4 weeks before study start;Refusal or inability to provide informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measures of dysregulated (metabolic) pathways (i.e. blood-brain barrier, glutamate regulation and neuroinflammation) within the entire brain and within subsegments (including but not limited to magnetic susceptibility/iron, resting-state fMRI, permeability measurements, measurement of metabolites like glutamate, NAA, choline, creatine and myo-Inositol, and T1 and T2 mapping), all acquired with 7 tesla (7T) MRI. | — |
Secondary
| Measure | Time frame |
|---|---|
| Inflammatory markers present in blood and stool samples, measures of fatigue and mood | — |
Countries
Netherlands
Contacts
Public ContactA.G. Kolk
Radboud Universitair Medisch Centrum
Outcome results
None listed