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

Identify Specific PBMC miRNAs as Biomarkers for IBD

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.

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Diseases

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 179

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • 2nd Affiliated Hospital, Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Patients aged 14-75 years old, diagnosed as CD or UC according to WHO criteria, are recruited at specialist IBD clinic. They are excluded if upper GI is the only involved part, had colectomy or in artificial opening status or have other autoimmune comorbidity.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Crohn's Disease Group; Patients are diagnosed as Crohn's disease and have no history of colectomy.
Ulcerative Colitis Group; Patients are diagnosed as ulcerative colitis and have no history of colectomy.
Healthy Control Group; Individuals that have no past medical history.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Crohn's Disease Activity Index (CDAI)	Crohn's Disease Activity Index (CDAI) has been developed to assess whether or not the pathology of Crohn's disease is progressing. The index is the sum of 8 components, to each of which is assigned a specific weight. <150 suggests remission, 151-219 suggests mild activity, 220-450 suggests moderate activity, >450 suggests severe activity	2 months
Mayo Score	The full Mayo Score evaluates ulcerative colitis stage, based on four parameters: stool frequency, rectal bleeding, endoscopic evaluation and Physician's global assessment. Each parameter of the score ranges from zero (normal or inactive disease) to 3 (severe activity). 0-2 suggests remission, 3-5 suggests mild activity,6-10 suggests moderate activity, >10 suggests severe activity	2 months

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2019
• Primary Completion (Actual): May 31, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: January 16, 2020
• First Submitted That Met QC Criteria: February 4, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): April 21, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Intestinal Diseases
• Other Study ID Numbers: SAHZJU2019-189

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No