inflammatory bowel disease (IBD)
Conditions
Interventions
Gold Standard:The final diagnosis requires at least two experienced gastroenterologists and pathologists.
Index test:Detection of Y mix RNA and XIST RNA expression levels on the surface of peripheral blood mononuclear cells and B cells
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
14 Years to 75 Years
Inclusion criteria
Inclusion criteria: Participants in all groups (UC, CD, NC, and IBS) must meet the following common criteria: 1.Aged between 14 and 75 years (inclusive). 2.Capable of understanding the study content and voluntarily signing the written informed consent form. 3.Willing and able to comply with all procedures stipulated in the study protocol. In addition, each specific group must meet the following additional criteria: 1. UC and CD Groups Diagnosed with Ulcerative Colitis or Crohn's Disease based on a comprehensive assessment of clinical manifestations, laboratory tests, imaging, endoscopy, and histopathology, in accordance with the Chinese Consensus on the Diagnosis and Treatment of Crohn's Disease (2023, Guangzhou), the Chinese Consensus on the Diagnosis and Treatment of Ulcerative Colitis (2023, Xi'an), or other recognized international guidelines. Scheduled to undergo colonoscopy as part of routine clinical management due to disease condition. 2. Disease Control Group (IBS) Clinically diagnosed with IBS according to the Rome IV criteria. Presenting with gastrointestinal symptoms similar to IBD (e.g., abdominal pain, diarrhea) and scheduled to undergo colonoscopy to clarify the diagnosis. Colonoscopy reveals no definite organic lesions (such as inflammation, ulcers, or tumors), or histopathological results do not support the diagnosis of IBD or other inflammatory bowel diseases. 3. Healthy Control Group (NC) Individuals scheduled to undergo colonoscopy for routine health examination or screening (e.g., colorectal cancer screening). Colonoscopy results are completely normal, with no organic or inflammatory lesions. No history of chronic digestive diseases or autoimmune diseases.
Exclusion criteria
Exclusion criteria: 1. Pregnancy and Lactation Females who are pregnant, breastfeeding, or planning to become pregnant during the 6-month study period. 2. Severe Organ Dysfunction Patients with severe cardiac, hepatic, or renal insufficiency (e.g., NYHA Class III-IV heart failure, Child-Pugh Class C, or estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73m²). 3. Other Severe Gastrointestinal Diseases Patients with other severe gastrointestinal conditions, such as colorectal cancer, active gastrointestinal infections (e.g., Clostridioides difficile infection, bacillary dysentery), microscopic colitis, radiation enteritis, or diverticulitis. 4. Uncontrolled Systemic Infections Patients with any uncontrolled active systemic infection, such as HIV infection, active tuberculosis, or untreated Hepatitis B or C infection. 5. Malignancy and Severe Comorbidities Patients with malignancy, or any severe hematological, immunological, neurological, or psychiatric disorders that, in the investigator's judgment, make them unsuitable for participation in this study. 6. Contraindications to Endoscopy Patients with contraindications to endoscopy, such as severe coagulation dysfunction, recent myocardial infarction, or extremely high risk of gastrointestinal perforation. 7. Recent Clinical Trial Participation Patients who have participated in other interventional clinical studies within the last 3 months. 8. Investigator's Discretion Any other condition that, in the opinion of the investigator, may interfere with study evaluations, affect participant safety, or result in poor compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The expression level of Y mix RNA on the surface of peripheral blood mononuclear cells;The expression level of XIST RNA on the surface of peripheral blood mononuclear cells;The expression level of Y mix RNA on the surface of peripheral blood B cells;The expression level of XIST RNA on the surface of peripheral blood B cells;Sensitivity;Specificity;ROC curve;Youden index;positive predictive value;negative predictive value;Likelihood Ratio; | — |
Countries
China
Contacts
Public ContactWanwei Zheng; Zhongguang Luo
Huashan Hospital, Fudan University
Outcome results
None listed