Identify Specific Peripheral Blood Mononuclear Cell (PBMC) MiRNA as Biomarkers for Inflammatory Bowel Disease (IBD)

Zhejiang University

Status: Completed

Conditions: Inflammatory Bowel Diseases

Study type: Observational

Funder types: Other

Identifiers

NCT04256538

SAHZJU2019-189

Details and patient eligibility

About

To find high sensitivity and specificity biomarkers to better diagnose and monitor progression of inflammatory bowel disease (IBD). In this study, we try to find miRNAs that can used to diagnose or monitor progression of IBD by exploring differential expression of miRNAs in peripheral blood mononuclear cells (PBMCs) from Crohn's disease, ulcerative colitis and healthy controls. And we further validate these miRNAs in a larger population to assess their function as biomarkers.

Full description

Incidence of inflammatory bowel disease (IBD) has been rising in the past decades. However, diagnosis and differential diagnosis of IBD still lack gold standard. To diagnose IBD, physicians need to combine clinical manifestation, lab results, image examination, endoscopy examination and pathology. After diagnosis, patients still need to monitor their disease progression. The most accurate way is to do endoscopy examination, however, endoscopy examination is an invasive, expensive and uncomfortable procedure. At present, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR) and fecal calprotectin are used as main noninvasive biomarkers to monitor progression routinely. But their specificities are still unsatisfactory. So, it's urgent to find high sensitivity and specificity biomarkers to better diagnose and monitor progression of IBD. In this study, we try to find miRNAs that can used to diagnose or monitor progression of IBD by exploring differential expression of miRNAs in peripheral blood mononuclear cells (PBMCs) from Crohn's disease, ulcerative colitis and healthy controls. And we further validate these miRNAs in a larger population to assess their function as biomarkers.

Enrollment: 179 patients

Sex: All

Ages: 14 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Diagnosed as Crohn's disease (CD) or ulcerative colitis (UC) according to World Health Organization (WHO) criteria
• Vital signs are stable

Exclusion criteria

• Refuse to sign consent
• Refuse to do examination to assess their disease progression
• CD patients only upper gastrointestinal tract (GI) is involved (L4)
• Had colectomy or in artificial opening status
• Have other autoimmune comorbidity
• Had severe infection within a week
• Had surgery within a month
• Have malignant tumor
• Pregnancy or lactation

Trial design

179 participants in 3 patient groups

Crohn's Disease Group

Description:

Patients are diagnosed as Crohn's disease and have no history of colectomy.

Ulcerative Colitis Group

Description:

Patients are diagnosed as ulcerative colitis and have no history of colectomy.

Healthy Control Group

Description:

Individuals that have no past medical history.