Clinical trial NCT04256538: Identify Specific Peripheral Blood Mononuclear Cell (PBMC) MiRNA as Biomarkers for Inflammatory Bowel Disease (IBD)
Official title: Identify Specific PBMC miRNAs as Biomarkers for IBD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 179
Sex: ALL
Minimum age (years): 14
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Crohn's Disease Activity Index (CDAI)
timeFrame: 2 months
measure: Mayo Score
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: