This is a prospective, single-center, observational cohort study that will enroll 250 participants: 50 with active Crohn's disease, 50 with Crohn's disease in remission, 50 with active ulcerative colitis, 50 with ulcerative colitis in remission, and 50 healthy volunteers. Using a novel visual sampling capsule endoscope, intestinal fluid will be collected non-invasively from four intestinal regions: the upper jejunum, the upper ileum, the terminal ileum, and the colon. Saliva and stool samples will also be collected. All samples will be analyzed using 16S rRNA sequencing, metagenomic sequencing, and non-targeted metabolomics. The study aims to characterize the distribution and function of gut microbiota and metabolites across different intestinal regions in patients with inflammatory bowel disease (IBD), to compare active-stage and remission-stage disease, and to compare IBD patients with healthy volunteers, while evaluating the feasibility and safety of the visual sampling capsule endoscope in IBD patients.
Male or female, aged 18 years or older and 80 years or younger;
Willing and able to complete the study assessments, including repeated capsule endoscopy examinations and daily records of diet, activity, and defecation;
Willing to provide fecal (stool), saliva, and intestinal fluid samples and to consent to long-term storage of the provided samples for research purposes;
Willing to avoid vigorous physical activity during participation in this clinical trial;
Other gastrointestinal diseases, including gastrointestinal cancer, indeterminate colitis, infectious colitis or colitis with a definite etiology, and toxic megacolon (for the UC cohort, Crohn's disease is also excluded; for the CD cohort, ulcerative colitis is also excluded);
Known or suspected gastrointestinal obstruction, stricture, diverticulum, fistula, or perforation;
Severe cardiac, pulmonary, or renal insufficiency, liver cirrhosis, hepatic insufficiency, or hematologic diseases;
Known or suspected malignant tumors, acute severe illness, or other end-stage diseases, or concomitant diseases with an expected survival of less than 12 months;
Participants will be selected from healthy volunteers and patients receiving care at the study hospital (Changhai Hospital). The study population will include five groups: healthy controls, patients with active Crohn's disease, patients with Crohn's disease in remission, patients with active ulcerative colitis, and patients with ulcerative colitis in remission.Patients with inflammatory bowel disease (IBD) will be identified through outpatient clinics, inpatient wards, and routine clinical evaluation. Participants will be recruited using a non-probability sampling approach from outpatient clinics, inpatient wards, and healthy volunteer sources at Changhai Hospital.
Cohort
Prospective
Not listed
Microbiota Analysis
Studying the gut microbiota of patients diagnosed with inflammatory bowel disease to identify microorganism factors that induce disease, predictive biomarkers of the active and remission stages, and predictors of clinical prognosis.
Metabolism Analysis
Studying the gut metabolites of patients with inflammatory bowel disease (IBD) to identify disease-triggering factors, biomarkers predictive of the active and remission stages, and indicators of prognosis.
The feasibility of the sampling capsule endoscopy system in collecting fluids from different intestinal segments in patients with IBD
The total successful rate of SCE in sampling fluids in intestinal segments. A successful sampling procedure conducted by SCE was defined when the following conditions were met simultaneously: 1) accurately recognization of target intestinal areas. 2) the intestinal liquid can be successfully collected in the sampling chamber.
Sampling time
The total time for sampling intestinal fluids of a SCE.
Sampling volume
The overall volume of samples obtained by a SCE during a single examination.
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