nderstanding the mechanisms of fatigue and relapse in IBD patients, and the evaluation of an innovative health patch

Recruiting

Conditions: Crohn's Disease
Inflammatory Bowel Diseases
Ulcerative Colitis
10017969

Registration Number: NL-OMON54221

Lead Sponsor: Amsterdam UMC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 100

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 2:
- Active CD (HBI > 4, calprotectin > 250µg/g, CRP > 5mg/l)
Group 3:
- UC in remission (SCCAI <=2, calprotectin < 250µg/g, CRP < 5mg/l)
Group 4:
- Active UC (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

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)

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Disease activity and fatigue severity based on biomarkers, gene expression<br /><br>levels and difference in 72 hours of continuous health patch measures (heart<br /><br>rate, heart rate variability, respiratory rate, posture, activity count).<br /><br>Associations between these parameters and conventional serum CRP, fecal<br /><br>calprotectin, intestinal ultrasound (IUS), HBI and SCCAI score, and<br /><br>multidimensional fatigue inventory (MFI) score.<br /><br><br /><br>Primary objectives:<br /><br>1. To investigate the mechanism of fatigue and inflammation in IBD using<br /><br>clinical biomarkers, transcriptomic and epigenetic sequencing<br /><br>2. To evaluate the discriminative capacity of an innovative health patch in<br /><br>differentiating fatigue and disease activity in a subgroup of UC patients</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objectives:<br /><br>1. To determine associations between clinical biomarkers, gene expression and<br /><br>methylation levels, fatigue, quality of life and conventional clinical,<br /><br>biochemical and radiological parameters of remission and relapse in IBD<br /><br>2. To develop a predictive algorithm based on the health patch measurements<br /><br>(i.e. HR, HRV, respiratory rate, temperature, posture), validated by the<br /><br>aforementioned clinical and biochemical analyses</p><br>