Crohn's Disease Inflammatory Bowel Diseases Ulcerative Colitis
Conditions
Interventions
None listed
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: All groups: - Aged between 18 and 75 years - Male and female Group 3 and 4: - Willingness to abstain from visiting a sauna, or swimming during the 72h monitoring period - Willingness to wear a shirt at night (to prevent uncontrolled friction on electrodes during sleep) - Willingness to dry area where the electrodes are applied in a dipping fashion after washing Group 1: - CD in remission (HBI 4, calprotectin > 250µg/g, CRP > 5mg/l) Group 3: - UC in remission (SCCAI 2, calprotectin > 250µg/g, CRP > 5mg/l) Group 5: - No CD or UC diagnosis, no intestinal complaints (diarrhea, blood in stool, pain)
Exclusion criteria
Exclusion criteria: 1. Inability to read, give or sign informed consent 2. Inability to give blood 3. Comorbidity with severe disease 4. Having any cardiac implants 5. Wounded or particular sensitive skin (e.g. skin-rash, discoloration, scars, or open wounds at area of investigation) 6. Pregnant or lactating 7. Known to be allergic to silicone, acrylic chemicals or medical gels 8. Use of medication known to influence the skin at the test area (such as medical creams of lotions)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease activity and fatigue severity based on biomarkers, gene expression levels and difference in 72 hours of continuous health patch measures (heart rate, heart rate variability, respiratory rate, posture, activity count). Associations between these parameters and conventional serum CRP, fecal calprotectin, intestinal ultrasound (IUS), HBI and SCCAI score, and multidimensional fatigue inventory (MFI) score. Primary objectives: 1. To investigate the mechanism of fatigue and inflammation in IBD using clinical biomarkers, transcriptomic and epigenetic sequencing 2. To evaluate the discriminative capacity of an innovative health patch in differentiating fatigue and disease activity in a subgroup of UC patients | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives: 1. To determine associations between clinical biomarkers, gene expression and methylation levels, fatigue, quality of life and conventional clinical, biochemical and radiological parameters of remission and relapse in IBD 2. To develop a predictive algorithm based on the health patch measurements (i.e. HR, HRV, respiratory rate, temperature, posture), validated by the aforementioned clinical and biochemical analyses | — |
Countries
Netherlands
Outcome results
None listed