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The Comparison Between the Biomarkers in Inflammatory Bowel Disease Patients and General Control Group

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ClinicalTrials.gov Identifier: NCT03778918
Recruitment Status : Recruiting
First Posted : December 18, 2018
Last Update Posted : December 18, 2018
Sponsor:
Collaborators:
Incheon St.Mary's Hospital
St. Vincent's Hospital-Manhattan
Daejeon St. Mary's hospital
Information provided by (Responsible Party):
Bo-In Lee, Seoul St. Mary's Hospital

Brief Summary:
The aims of this study is to investigate a blood-based biomarker that can replace endoscopy in patients with inflammatory bowel disease. For this purpose, blood sample of patients wiht inflammatory bowel disease (ulcerative colitis, Crohn 's disease) was collected at the same time the endoscopy is performed, stored after centrifugation, and analyzed accordingly. Selected biomarkers from the blood sample were investigated to compare those of patients with inflammatory bowel disease and those of general controls. Males and females over the age of 19 participated in the study and are excluded if they have chronic kidney disease or blood clotting disease. The outcome is a find of a blood-based biomarker that best reflects a disease activity.

Condition or disease Intervention/treatment
Inflammatory Bowel Diseases Irritable Bowel Syndrome Other: inflammatory bowel disease Other: IBS or Normal Control

Detailed Description:
Inflammatory bowel disease refers to chronic inflammation of the unknown origin that occurs in the intestine. It usually refers to ulcerative colitis and Crohn's disease, which are idiopathic inflammatory bowel diseases. While it had been known to be a common disease in the western world, in recent decades the incidence of ulcerative colitis and Crohn's disease has rapidly increased in Korea as well. Endoscopic examination is a gold standard in order to determine the activity of inflammatory bowel disease, but it is hardly performed due to the cost and time of a test. Therefore, it is necessary to find a blood-based biomarker that replaces endoscopy. The objective of the study is to identify a new inflammatory marker that replaces endoscopy by comparing blood samples of patients with inflammatory bowel disease with those of general controls.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 36 Months
Official Title: The Comparison Between That Expression Pattern and Disease Activity of Variable Biomarkers in Inflammatory Bowel Disease Patients and General Control Group. Multicenter, Prospective Study
Actual Study Start Date : August 1, 2016
Estimated Primary Completion Date : March 17, 2019
Estimated Study Completion Date : February 28, 2020

Group/Cohort Intervention/treatment
inflammatory bowel disease
inflammatory bowel disease such as Ulcerative colitis and Crohn's disease
Other: inflammatory bowel disease
blood based biomarkers in IBD such as REG3 alpha, serum calprotectin and hs-CRP

Other: IBS or Normal Control
blood based biomarker compared normal control with IBD

IBS or Normal Control
irritable bowel syndrome patients normal patients
Other: inflammatory bowel disease
blood based biomarkers in IBD such as REG3 alpha, serum calprotectin and hs-CRP

Other: IBS or Normal Control
blood based biomarker compared normal control with IBD




Primary Outcome Measures :
  1. measurement of blood-based biomarkers to predict disease activity 1 [ Time Frame: within 12 weeks of the blood sampling ]
    REG3 alpha (ng/mL)

  2. measurement of blood-based biomarkers to predict disease activity 2 [ Time Frame: within 12 weeks of the blood sampling ]
    hs-CRP (mg/dL)

  3. measurement of blood-based biomarkers to predict disease activity 3 [ Time Frame: within 12 weeks of the blood sampling ]
    serum calprotectin (ng/mL)


Secondary Outcome Measures :
  1. Age (years) [ Time Frame: at the time of study enrolled ]
    age at the time of study enrolled

  2. Gender (M/F) [ Time Frame: at the time of study enrolled ]
    male of female

  3. disease duration (months) [ Time Frame: at the time of study enrolled ]
    duration of disease

  4. disease onset (years) [ Time Frame: at the time of study enrolled ]
    age at which the disease begins


Biospecimen Retention:   Samples With DNA
Blood, Biopsy tissue, Stool


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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
inflammatory bowel disease (ulcerative colitis, Crohn's Dz.) irritable bowel syndrome normal control
Criteria

Inclusion Criteria:

  • people who receive colonoscopy
  • people who sign the consent
  • having inflammatory bowel disease (ulcerative colitis, Crohn's Dz.) and irritable bowel syndrome

Exclusion Criteria:

  • those aged over 75 years
  • the disabled
  • pregnant women
  • chronic renal diseases (CLcr <50ml/min)
  • blood coagulopathy (PT INR > 1.5, aPTT > 45 seconds, or platelet count < 50,000/mm)
  • people who refuse to sign the consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03778918


Contacts
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Contact: Bo-In Lee, MD. Ph.D. 82-10-8367-1055 gidoc4u@gmail.com
Contact: Seungjun Kim, MD. 82-10-8786-2799 gmt475@gmail.com

Locations
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Korea, Republic of
Division of Gastroenterology; Seoul St. Mary's hospital Recruiting
Seoul, Korea, Republic of, 137-701
Contact: Bo-In Lee, MD, PhD    82-10-8367-1055    gidoc4u@gmail.com   
Principal Investigator: Bo-In Lee, MD, PhD         
Sponsors and Collaborators
Bo-In Lee
Incheon St.Mary's Hospital
St. Vincent's Hospital-Manhattan
Daejeon St. Mary's hospital
Investigators
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Principal Investigator: Bo-In Lee, MD. Ph.D. Seoul St. Mary's Hospital

Additional Information:

Publications:
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Responsible Party: Bo-In Lee, Professor, MD, PhD., Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT03778918     History of Changes
Other Study ID Numbers: XC18TEDI0027
First Posted: December 18, 2018    Key Record Dates
Last Update Posted: December 18, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bo-In Lee, Seoul St. Mary's Hospital:
REG3 alpha
IBD
biomarker
ulcerative colitis
serum calprotectin

Additional relevant MeSH terms:
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Intestinal Diseases
Irritable Bowel Syndrome
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases, Functional
Colonic Diseases
Gastroenteritis