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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

179 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-15

Study Completion Date

2020-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Inflammatory Bowel Diseases

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Crohn's Disease Group

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

No interventions assigned to this group

Ulcerative Colitis Group

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

No interventions assigned to this group

Healthy Control Group

Individuals that have no past medical history.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

14 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes