Additional consent provisions for collection and use of participant data and biological specimens {26b}
DISEASE
After obtaining written consent from the patients, the different eligibility criteria are recorded in the study’s research database (Redcap database hosted by Odense Patient Exploring Network (OPEN) situated in Denmark). This includes information on diagnosis, the onset of disease, duration of disease, disease activity by clinical scores and fecal plus blood biomarkers, and type of pharmacological treatment 3 months before inclusion. The written consent includes a permission to store blood samples and fecal samples in a research biobank also hosted by OPEN. The written consent includes a permission for the research group and regulatory authority to obtain health status from the medical record to monitor the quality and safety of the intervention.