Inflammatory Bowel Disease Tracker

Recruiting

Conditions: Inflammatory bowel disease - Crohn's disease or ulcerative colitis
10017969

Registration Number: NL-OMON46657

Lead Sponsor: Center for Microbiome Informatics and Therapeutics, Massachusetts Institute of Technology

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

• 18 years of age or older
• Be able to provide written informed consent prior to screening and to comply with the requirements of the study protocol
• Be able to read and write Dutch sufficiently
• Be able and comfortable to use new technology: the app and the smartwatch for 12 months
• Live / work in proximity of the UMCG to permit sample collection by UMCG clinical team
• Have had diagnosis of ulcerative colitis or Crohn*s Disease confirmed by a clinician for a disease duration of more than 2 years
• Have had quiescent ulcerative colitis or Crohn*s disease for the past 3 months or longer
• Have had most recent episode of active disease within past 24 months
• Have had a stable IBD medication regimen for at least 3 months

Exclusion Criteria

• If female, is pregnant or is breast feeding, or intends to become pregnant within the 12- month study period
• Unable to provide informed consent or unwilling to participate
• Use of oral or intravenous antibiotics within 4 weeks prior to screening
• Evidence of untreated infection e.g. Clostridium diffiicile
• Confirmed diagnosis of other serious disease unrelated to ulcerative colitis or Crohn*s disease
• Current alcohol or drug abuse

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Changes in the gut microbiome, metabolome (in stool, in blood, and in urine),<br /><br>and physiological biomarkers in correlation with patients* health or disease<br /><br>state over the 12-month study period. At the end of the 12-month study period,<br /><br>in all patients, we will have profiled numerous biomarkers, as well as tracked<br /><br>their general well-being and disease activity using the clinical disease<br /><br>activity scores (the Simple Clinical Colitis Activity Index for ulcerative<br /><br>colitis, or the Harvey Bradshaw Index for Crohn*s Disease).</p><br>

Secondary Outcome Measures