Capsule & Omics for pRedicting Exacerbation of Crohn's Disease

Part I - A retrospective study will use stored capsule and clinical datasets from 120 previously enrolled CD patients in remission, who underwent capsule based 24-months monitoring as part of two prior similar research projects (60 in each of the Israeli Inflammatory bowel disease Research Nucleus (IIRN), IIRN-I and IIRN-II-CURE- projects), aiming to predict and prevent flares based on capsule studies. The investigators will now utilize the accumulated visual data to develop AI-based complete film readouts and integrate the resultant visual omics data with previously derived microbiome and biomarker data, to serve as a discovery cohort for machine learning models predicting clinical exacerbation in patients in remission, which was witnessed in 27% of IIRN-I cohort within the 24m study. Part II - A prospective observational study will enroll a new IIRN-III cohort of 60 (+6 attrition-considered) Crohn's Disease patients\>16 years old in clinical remission. The investigators will deliberately use similar inclusion, monitoring design and outcome definitions as IIRN-I \& II studies, to allow cross-cohort comparative validity. Procedures will include baseline colonoscopy, pan-enteric capsule and magnetic resonance enterography/Intestinal ultrasound, and thereafter serial capsule studies or every 6 months for 24 months. Newly acquired Omics will include baseline mucosal +colonic wash transcriptomics obtained during the baseline colonoscopy, serial dense stool microbiome and blood metabolomics, and a computerized frequency questionnaire, diet omics data. A densely sampled 24 months stool will be used to develop novel multi-omics tools predicting flares. The investigators will also use the datasets to explore the mechanisms and pathways involved in triggering remission transition into a clinical flare. Follow- up can optionally extend to 36 months.