inflammatory bowel disease
Conditions
Interventions
Remission-stage Crohn's disease patients:None
Active-stage Crohn's disease patients:None
Remission-stage ulcerative colitis patients:None
Active-stage ulcerative colitis patients:None
Sponsors
Shanghai Changhai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: General Inclusion Criteria: 1. Male or female, aged >=18 years and <=80 years; 2. Willing to provide fecal samples, saliva samples, and intestinal fluid samples, agree to long-term storage of the provided samples for research purposes; 3. Agree to avoid vigorous physical activity during participation in this clinical trial; 4. Agree to participate in this clinical trial and sign the informed consent form. Inclusion Criteria for Patients with Inflammatory Bowel Disease (IBD): 1. Patients diagnosed with inflammatory bowel disease (IBD) by at least one of the following clinically accepted diagnostic methods: Endoscopy (e.g., colonoscopy) showing typical IBD manifestations; Histopathological examination consistent with IBD features; Imaging studies (e.g., CTE, MRE) showing typical IBD changes; Comprehensive assessment by a digestive specialist based on clinical presentation, laboratory tests (e.g., fecal calprotectin, inflammatory markers), and exclusion of infectious enteropathy. Inclusion Criteria for Healthy Subjects: 1. No chronic gastrointestinal symptoms (e.g., abdominal pain, diarrhea, constipation, hematochezia, bloating); 2. No prior history of inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), celiac disease, or other chronic gastrointestinal disorders; 3. Have undergone a colonoscopy within the past year with normal results, or if no colonoscopy has been performed, have a negative fecal occult blood test and no related symptoms.
Exclusion criteria
Exclusion criteria: 1. Known or suspected gastrointestinal obstruction, stricture, diverticulum, or fistula; 2. Individuals with dysphagia; 3. Known or suspected malignant tumors, acute severe illness, or other end-stage diseases; 4. Patients with severe cardiac insufficiency, renal failure, hepatic insufficiency, or hematologic diseases; 5. Individuals planning to undergo magnetic resonance imaging (MRI); 6. Pregnant women; 7. Poor general condition, unable to tolerate sampling capsule endoscopy; 8. Currently receiving or planning to receive medication for other diseases; 9. Any form of active substance abuse or dependence (including drug or alcohol abuse), any unstable physical or mental illness, any malignant lesion in any location or system, or any chronic condition that the investigator believes may interfere with the conduct of the study; 10. Inability to undergo surgery or refusal to undergo any abdominal surgery (if capsule retention occurs, it cannot be surgically removed); 11. Use of antibiotics within three months; 12. Participation in another clinical trial within three months or current participation in another clinical trial; 13. Any other factors that the investigator considers unsuitable for enrollment or that may affect the subject's participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Distribution characteristics of microbiota and metabolites in different intestinal regions of patients with inflammatory bowel disease; | — |
Secondary
| Measure | Time frame |
|---|---|
| Regional differences in the distribution and functional features of gut microbiota and metabolites in patients with Crohn's disease.;Regional differences in the distribution and functional features of gut microbiota and metabolites in patients with ulcerative colitis.;Evaluation of Sampling Efficiency of a Sampling Capsule Endoscope; | — |
Countries
China
Contacts
Public ContactZhuan Liao
Department of Gastroenterology, the First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital), Shanghai , China
Outcome results
None listed