Inflammatory bowel disease - Crohn's disease or ulcerative colitis
Conditions
Interventions
None listed
Sponsors
Center for Microbiome Informatics and Therapeutics, Massachusetts Institute of Technology
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the gut microbiome, metabolome (in stool, in blood, and in urine), and physiological biomarkers in correlation with patients* health or disease state over the 12-month study period. At the end of the 12-month study period, in all patients, we will have profiled numerous biomarkers, as well as tracked their general well-being and disease activity using the clinical disease activity scores (the Simple Clinical Colitis Activity Index for ulcerative colitis, or the Harvey Bradshaw Index for Crohn*s Disease). | — |
Countries
Netherlands
Outcome results
None listed